Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
For import permit declaration of an accessory only, the declarants may declare the HS code as appropriate for the accessory. If the HS Code falls under MDB control,
the declarant may declare the Accessory Product code as HSAMDZ01000 [Import of an accessory (only) of a medical device on Transition List]
Transition List
No.
Job Reference No. Registrant
TLCNB00031
MD11536075H
CHEE SANG DENTAL
SUPPLY PTE LTD
TLCNB00031
TLCNB00031
TLCNB00031
TLCNB00032
MD11536080M
CHEE SANG DENTAL
SUPPLY PTE LTD
TLCNB00032
Device name submitted under
"Device Info" section in
MEDICS
NAKANISHI PANA-MAX HIGH
SPEED AIR TURBINE
HANDPIECES
NAKANISHI MINIMA AND
MINIMA-N HIGH SPEED ULTRA
MINIATURE HEAD AIR TURBINE
HANDPIECES
NAKANISHI MACH-LITE XT
HIGH SPEED AIR TURBINE
HANDPIECES
NAKANISHI PHATELUS 45 HIGH
SPEED AIR TURBINE
HANDPIECES
NAKANISHI ENDO-MATE TC
CORDLESS HANDPIECE
SYSTEM
NAKANISHI TI-MAX ELECTRIC
MICROMOTOR SYSTEM
HS CODE
HSA Product Code
90184100
HSAMDB01003
90184100
HSAMDB01003
90184100
HSAMDB01003
90184100
HSAMDB01003
90184100
HSAMDB01003
90184100
HSAMDB01003
TLCNB00033
MD11536083P
CHEE SANG DENTAL
SUPPLY PTE LTD
NAKANISHI PROPHY-MATE
90184900
TOOTH CLEANING HANDPIECE
REFER TO CRPNS
TLCNB00034
MD11536087T
CHEE SANG DENTAL
SUPPLY PTE LTD
NAKANISHI VARIOS 750 MULTI- 90184900
FUNCTION ULTRA SONIC
SCALERS AND TIPS
NAKANISHI VARIOS 560 MULTI- 90184900
FUNCTION ULTRA SONIC
SCALERS AND TIPS
NAKANISHI VARIOS 150 BUILT- 90184900
IN MODULE ULTRASONIC
SCALERS AND TIPS
REFER TO CRPNS
TLCNB00034
TLCNB00034
TLCNB00034
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
MD11536492I
NAKANISHI VARIOS 350 MULTIFUNCTION ULTRA SONIC
SCALERS AND TIPS
COVIDIEN PRIVATE LIMITED USS AUTO SUTURE ENDO
RETRACT II ROTICULATOR
USS AUTO SUTURE ENDO
SCIZ? DISPOSABLE
INSTRUMENT WITH UNIPOLAR
CAUTERY
USS AUTO SUTURE
ROTICULATOR ENDO MINISHEARS DISPOSABLE
LAPAROSCOPIC HAND
INSTRUMENT
USS AUTO SUTURE SPRINGGRIP* DISPOSABLE
ANCHORING DEVICE
USS AUTO SUTURE
SURGIWAND* II DISPOSABLE
SUCTION/IRRIGATION DEVICE
REFER TO CRPNS
REFER TO CRPNS
90184900
REFER TO CRPNS
90189090
HSAMDB01009
90189030
REFER TO CRPNS
90189030
REFER TO CRPNS
90183990
HSAMDB01010
90189030
REFER TO CRPNS
90189090
HSAMDB01010
30061090
HSAMDB01010
30061090
HSAMDB01010
90183990
HSAMDB01010
90189090
HSAMDB01009
USS AUTO SUTURE ENDO MINI- 90189090
RETRACT DISPOSABLE
INSTRUMENT
USS AUTO SUTURE
90189030
ROTICULATOR ENDO DISSECT
DISPOSABLE LAPAROSCOPIC
HAND INSTRUMENT
HSAMDB01010
USS AUTO SUTURE ENDO
STITCH? SINGLE USE
SUTURING DEVICE
HSAMDB01010
USS AUTO SUTURE ENDO
CATCH? SINGLE USE
SPECIMEN POUCH
USS AUTO SUTURE ENDO GIA
UNIVERSAL SINGLE USE
STAPLER
USS AUTO SUTURE ENDO
CLOSE? SINGLE USE
SUTURING DEVICE
USS AUTO SUTURE
REPOSABLE STEP*
EXPANDABLE NEEDLE
SYSTEM
USS AUTO SUTURE
ROTICULATOR ENDO
RETRACT PADDLE
DISPOSABLE LAPAROSCOPIC
HAND INSTRUMENT
Page 1
30061090
REFER TO CRPNS
Remarks
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
TLCNB00040
Device name submitted under
"Device Info" section in
MEDICS
USS AUTO SUTURE ENDO
GRASP? DISPOSABLE
INSTRUMENT
USS AUTO SUTURE ENDO
LUNG? DISPOSABLE
INSTRUMENT
USS AUTO SUTURE ENDO
CATCH? GOLD SINGLE USE
SPECIMEN POUCH
USS AUTO SUTURE
SURGINEEDLE* SINGLE-USE
PNEUMOPERITONEUM
NEEDLE
USS AUTO SUTURE
ROTICULATOR ENDO GRASP?
DISPOSABLE LAPAROSCOPIC
HAND INSTRUMENT
HS CODE
HSA Product Code
90189030
REFER TO CRPNS
90189030
REFER TO CRPNS
90189090
HSAMDB01010
90183990
HSAMDB01010
90189030
REFER TO CRPNS
UNITED STATES SURGICAL
AUTOSUTURE? BLUNT TIP
TROCAR
USS AUTO SUTURE ENDO
RETRACT? MAXI DISPOSABLE
INSTRUMENT
USS AUTO SUTURE
SURGIWAND? II DISPOSABLE
SUCTION/IRRIGATION DEVICE
90183990
HSAMDB01010
90189090
HSAMDB01010
90189030
REFER TO CRPNS
USS AUTO SUTURE ENDO
RETRACT? DISPOSABLE
INSTRUMENT
USS AUTO SUTURE ENDO
BABCOCK? DISPOSABLE
CLAMP
USS AUTO SUTURE ENDO
PEANUT? DISPOSABLE
INSTRUMENT
COVIDIEN PRIVATE LIMITED USS AUTO SUTURE
VERSASTEP* SINGLE USE
ACCESS SYSTEM
COVIDIEN PRIVATE LIMITED UNITED STATES SURGICAL
AUTOSUTURE? SPACEMAKER?
PLUS DISSECTOR SYSTEM
90189090
HSAMDB01010
90189090
HSAMDB01010
90189030
REFER TO CRPNS
90183990
HSAMDB01010
90189090
HSAMDB01009
MEDTRONIC
MEDTRONIC CLEARVIEW?
INTERNATIONAL, LTD.
INTRACORONARY SHUNTS
COVIDIEN PRIVATE LIMITED KENDALL KANGAROO? PUMP
SETS
COVIDIEN PRIVATE LIMITED KENDALL ARGYLE THORASEAL CHEST DRAINAGE UNIT
90189090
HSAMDB01010
90183990
HSAMDB01004
90189030
REFER TO CRPNS
COVIDIEN PRIVATE LIMITED KENDALL ENTRISTAR SKIN
LEVEL TUBES
COVIDIEN PRIVATE LIMITED KENDALL SCD EXPRESS
COMPRESSION SYSTEM
COVIDIEN PRIVATE LIMITED COVIDIEN SHILEY EVAC
TRACHEOSTOMY TUBE
COVIDIEN PRIVATE LIMITED COVIDIEN SHILEY
PERCUTANEOUS
TRACHEOSTOMY TUBE
COVIDIEN PRIVATE LIMITED COVIDIEN SHILEY HILO
TRACHEOSTOMY TUBE
CUFFED WITH ADJUSTABLE
FLANGE, REINFORCED
COVIDIEN PRIVATE LIMITED KENDALL CURITY STOMACH
TUBE, LEVIN TYPE
COVIDIEN PRIVATE LIMITED KENDALL CURITY SUCTION
TUBE
COVIDIEN PRIVATE LIMITED KENDALL ARGYLE TROCAR
CATHETERS
COVIDIEN PRIVATE LIMITED DAR? ANAESTHESIA MASK
90183990
HSAMDB01010
90189030
REFER TO CRPNS
90192000
REFER TO CRPNS
90192000
REFER TO CRPNS
90192000
REFER TO CRPNS
90183990
HSAMDB01010
90183910
HSAMDB01010
90183910
HSAMDB01010
90200000
HSAMDB01002
TLCNB00044
MD11536663X
TLCNB00052
MD11536771B
TLCNB00056
MD11536835N
TLCNB00059
MD11537139F
TLCNB00060
MD11537147N
TLCNB00063
MD11537177R
TLCNB00070
MD11537231T
TLCNB00155
MD11539327J
TLCNB00156
MD11539332O
TLCNB00157
MD11539335R
TLCNB00174
MD11539776Q
TLCNB00175
MD11539778S
TLCNB00182
MD11539923H
TLCNB00199
MD11540120W
TLCNB00200
MD11540124A
COVIDIEN PRIVATE LIMITED COVIDIEN SHILEY STANDARD
TRACHEOSTOMY TUBE &
ACCESSORIES
90192000
REFER TO CRPNS
TLCNB00201
MD11540128E
90192000
REFER TO CRPNS
TLCNB00204
MD11540173X
84213990
HSAMDB01010
TLCNB00205
MD11540177B
84213990
HSAMDB01010
TLCNB00211
MD11540444I
COVIDIEN PRIVATE LIMITED COVIDIEN DAR? HEATED WIRE
CIRCUIT FOR MECHANICAL
VENTILATION
COVIDIEN PRIVATE LIMITED COVIDIEN DAR? ADULTPEDIATRIC MECHANICAL
FILTER
COVIDIEN PRIVATE LIMITED COVIDIEN DAR? ADULTPEDIATRIC ELECTROSTATIC
FILTER HME
COVIDIEN PRIVATE LIMITED COVIDIEN DAR? AEROSOL O2
THERAPY MASKS &
ACESSORIES/ OXYGEN
THERAPY NEBULIZER
90192000
REFER TO CRPNS
Page 2
Remarks
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
HSA Product Code
TLCNB00212
MD11540446K
REFER TO CRPNS
TLCNB00216
MD11541087B
Device name submitted under HS CODE
"Device Info" section in
MEDICS
COVIDIEN PRIVATE LIMITED COVIDIEN DAR? ADULT,
90192000
PEDIATRIC TO NEONATAL
VENTILATION CIRCUIT
BREATHING SYSTEM
COVIDIEN PRIVATE LIMITED KENDALL CURITY 100% LATEX- 90183910
FREE FOLEY CATHETERS
TLCNB00236
MD11542035N
COVIDIEN PRIVATE LIMITED COVIDIEN PURITAN BENNETT
CPAP INTERFACE SYSTEM
90200000
HSAMDB01002
TLCNB00248
MD11542407V
90192000
REFER TO CRPNS
TLCNB00249
MD11542409X
90183990
HSAMDB01010
TLCNB00250
MD11542411Z
90192000
REFER TO CRPNS
TLCNB00275
MD11543074M
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT HC
NEBULIZER ADAPTER WITH
OXYGEN DILUTER
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT
HEATER FOR MECHANICAL
NEBULIZATION WITH MN
ADAPTER
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT
JUNIOR NEBULIZER
MEDQUEST MARKETING
CARDINAL HEALTH ILLINOIS
PTE LTD
STERNAL/ILIAC BONE
MARROW ASPIRATION
NEEDLES
CARDINAL HEALTH JAMSHIDI?
CROWN BONE MARROW
BIOPSY/ASPIRATION NEEDLES
WITH MARROW ACQUISITION
CRADLE
90183990
HSAMDB01010
90183990
HSAMDB01010
CARDINAL HEALTH JAMSHIDI? 90183990
MENGHINI SOFT TISSUE
BIOPSY NEEDLE/SYRINGE
HSAMDB01010
TLCNB00275
TLCNB00275
TLCNB00275
TLCNB00275
TLCNB00275
TLCNB00275
TLCNB00275
TLCNB00275
HSAMDB01010
CARDINAL HEALTH TEMNO
EVOLUTION? SOFT TISSUE
BIOPSY NEEDLES
CARDINAL HEALTH TEMNO
SOFT TISSUE BIOPSY
NEEDLES
CARDINAL HEALTH TRU-CUT?
SOFT TISSUE BIOPSY
NEEDLES
CARDINAL HEALTH SAFE-TCENTESIS? CATHETER
DRAINAGE SYSTEM
CARDINAL HEALTH FINE
NEEDLE ASPIRATION
NEEDLES
CARDINAL HEALTH ACHIEVE?
SOFT TISSUE BIOPSY
NEEDLES
COVIDIEN PRIVATE LIMITED COVIDIEN DAR? TRIPLEX-DUO
CO-AXIAL BREATHING CIRCUIT
FOR ANAESTHESIA/ICU
90183990
HSAMDB01010
90183990
HSAMDB01010
90183990
HSAMDB01010
90183990
HSAMDB01010
90183990
HSAMDB01010
90183990
HSAMDB01010
90192000
REFER TO CRPNS
BAXTER SOLUTION SET, 68"
(1.7M), INJECTION SITE MALE
LUER SLIP ADAPTER
STERRAD® 100S
STERILIZATION SYSTEM
COMPACTFLO EVO
OXYGENATOR
FAST CATH HEMOSTASIS
INTRODUCER
MEDTRONIC NIMRESPONSE™ 2.0 SYSTEM AND
ACCESSORIES NERVE
INTEGRITY MONITOR
KAVO PROPHYFLEX® 3 - 2018
90189020
HSAMDB01010
84192000
HSAMDB01005
90200000
HSAMDB01002
90189090
HSAMDB01010
90181900
REFER TO CRPNS
90184900
REFER TO CRPNS
90189030
REFER TO CRPNS
TLCNB00277
MD11543169D
TLCNB00285
MD09516512W
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00303
MD10520773T
TLCNB00314
MD10521218W
TLCNB00317
MD10521539F
TLCNB00319
MD10522290C
JOHNSON & JOHNSON
MEDICAL SINGAPORE
SORIN GROUP ASIA PTE.
LTD.
ST. JUDE MEDICAL (S) PTE
LTD
MEDTRONIC
INTERNATIONAL, LTD.
TLCNB00331
MD10524512O
KAVO DENTAL SUPPLY
TLCNB00336
MD10524569T
NIHON KOHDEN
SINGAPORE PTE LTD
NIHON KOHDEN NEUROFAX
EEG-1200K
ELECTROENCEPHALOGRAPH
TLCNB00342
MD10524647T
BAXTER HEALTHCARE
(ASIA) PTE LTD
SOLUTION SET (PRODUCT
90183910
CODE 2C7554S)
EPIDURAL SET (PRODUCT
90183910
CODE EMC9655)
BAXTER VENTED PACLITAXEL 90189020
SET WITH PE-LINE TUBING,
0.22 MICRON DOWNSTREAM
HIGH PRESSURE FILTER AND 1
INJECTION SITE (PRODUCT
CODE 2C7553)
HSAMDB01010
BAXTER INFUSOR LV
(PRODUCT CODES 2C1008KP,
2C1009KP, 2C1063KP,
2C1071KJP, 2C1087KP)
HSAMDB01010
TLCNB00342
TLCNB00342
TLCNB00343
MD10524648U
BAXTER HEALTHCARE
(ASIA) PTE LTD
Page 3
90189020
HSAMDB01010
HSAMDB01010
Remarks
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
Device name submitted under HS CODE
"Device Info" section in
MEDICS
BAXTER INTERMATE
90189020
PORTABLE ELASTOMERIC
INFUSION SYSTEM, XLV, LV, SV
(PRODUCT CODES 2C1064K,
2C1730K, 2C1732K, 2C1734K,
2C1740K, 2C1742K, 2C1744K)
HSA Product Code
TLCNB00343
HALF DAY INFUSOR 5ML/HR
(PRODUCT CODE 2C1073KJP)
90189020
HSAMDB01010
TLCNB00343
MULTIDAY INFUSOR 0.5ML/HR
(PRODUCT CODE 2C1080KJP)
90189020
HSAMDB01010
TLCNB00343
MULTIRATE INFUSOR LV 5, 7,
12 ML/HR (PRODUCT CODE
2C9961KP)
MULTIRATE INFUSOR LV
2.0,3.0, 5.0 ML/HR (PRODUCT
CODE 2C1155KP)
TWO DAY INFUSOR 2ML/HR
(PRODUCT CODE 2C1075KJP)
90189020
HSAMDB01010
90189020
HSAMDB01010
90189020
HSAMDB01010
DUPLOCATH 180 (PRODUCT
CODE 1502325)
DUPLOCATH 180 (PRODUCT
CODE B2226700999006)
DUPLOCATH 25 (PRODUCT
CODE 1502323)
DUPLOCATH 25 (PRODUCT
CODE B2225700999008)
DUPLOCATH 35 M.I.S
(PRODUCT CODE
B2226700999010)
DUPLOCATH 35 M.I.S
(PRODUCT CODE 1502324)
PROGRESS HEALTHCARE
R57.507 ROCKET MUCUS
PTE. LTD.
SAMPLING SYRINGE
R57.508 ROCKET MUCUS
SAMPLING SYRINGE
PROGRESS HEALTHCARE
R59.503 ROCKET
PTE. LTD.
HAEMORRHOIDAL INJECTION
SET WITH STRAIGHT NEEDLE,
8"
FRESENIUS MEDICAL CARE BLOODLINE TUBING SYSTEM
SINGAPORE PTE. LTD.
90189090
HSAMDB01010
90189090
HSAMDB01010
90189090
HSAMDB01010
90189090
HSAMDB01010
90189090
HSAMDB01010
90189090
HSAMDB01010
90183110
HSAMDB01010
90183110
HSAMDB01010
90183200
HSAMDB01010
90189020
HSAMDB01010
RESMED ASIA OPERATIONS RESMED ULTRA MIRAGE II
PTY LIMITED (SINGAPORE
NASAL MASK
BRANCH)
90200000
HSAMDB01002
RESMED ULTRA MIRAGE MASK 90200000
HSAMDB01002
TLCNB00343
TLCNB00343
TLCNB00343
TLCNB00367
MD10525076G
TLCNB00367
TLCNB00367
TLCNB00367
TLCNB00367
TLCNB00367
TLCNB00376
MD10525633R
TLCNB00376
TLCNB00377
MD10525641Z
TLCNB00400
MD10527712Q
TLCNB00406
MD10528347B
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00406
Remarks
HSAMDB01010
TLCNB00431
MD11543392S
ASIA MEDICAL SUPPLIES
PTE LTD
SERVOX® DIGITAL
90189030
ELECTRONIC SPEECH DEVICE
REFER TO CRPNS
TLCNB00432
MD11544058I
REFER TO CRPNS
MD12549060S
90184900
REFER TO CRPNS
TLCNB00435
MD12553142S
90184100
HSAMDB01003
TLCNB00436
MD12553146W
MORITA TWINPOWER
TURBINE 4H DENTAL
HANDPIECES
OSSTEM SURGICAL
INSTRUMENT
NAKANISHI STRAIGHT AND
GEARED ANGLE DENTAL
IMPLANT HANDPIECES
NAKANISHI SGO-E MICRO SAW
HANDPIECE AND BLADES
90184900
TLCNB00434
MORITA MEDICAL
ENGINEERING SINGAPORE
PTE. LTD.
OSSTEM SINGAPORE PTE.
LTD.
CHEE SANG DENTAL
SUPPLY PTE LTD
90184900
REFER TO CRPNS
TLCNB00436
NAKANISHI SGT-E MICRO SAW 90184900
HANDPIECE AND BLADES
REFER TO CRPNS
TLCNB00436
NAKANISHI SGR-E MICRO SAW 90184900
HANDPIECE AND BLADES
REFER TO CRPNS
AMO LAMINAR® FLOW
INFUSION SLEEVE AND TEST
CHAMBER 20 GAUGE
SMITH & NEPHEW DIRECT
VIEW ARTHROSCOPE (NONAUTOCLAVABLE)
STRYKER INTERPULSE
SYSTEM
STRYKER HUMMER 4 SYSTEM
90185000
HSAMDB01008
REMOVED IN
VERSION 2
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
90189030
REFER TO CRPNS
90189030
REFER TO CRPNS
OCULUS FLEXCON? SUPER
THIN CONTACT LENS
MEDITECH ABPM-04
AMBULATORY BLOOD
PRESSURE MONITOR
MEDITECH MERLIN ECG
EVENT RECORDER
90013000
HSAMDB01008
90181900
REFER TO CRPNS
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90181100
HSAMDB01004
CHEE SANG DENTAL
SUPPLY PTE LTD
TLCNB00001
MD10526455H
AMO SINGAPORE PTE.
LIMITED
TLCNB00002
MD11530395V
SMITH & NEPHEW PTE
LIMITED
TLCNB00003
MD11532062Y
TLCNB00004
MD11532064A
TLCNB00005
MD11532238S
STRYKER SINGAPORE
PRIVATE LIMITED
STRYKER SINGAPORE
PRIVATE LIMITED
OCULUS PRIVATE LIMITED
TLCNB00006
MD11532331H
TLCNB00006
THERMAL INTERNATIONAL
(S) PTE. LTD.
Page 4
REMOVED IN
VERSION 9
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
TLCNB00006
TLCNB00006
TLCNB00006
TLCNB00007
MD11532355F
TLCNB00008
MD11532403B
BOSTON SCIENTIFIC ASIA
PACIFIC PTE. LTD.
STRYKER SINGAPORE
PRIVATE LIMITED
TLCNB00008
TLCNB00009
MD11532412K
TLCNB00010
MD11533029D
TLCNB00011
MD11533304S
TLCNB00012
MD11533379P
TLCNB00013
MD11533542W
TLCNB00014
MD11533559N
TLCNB00015
MD11533653D
STRYKER SINGAPORE
PRIVATE LIMITED
ALCON PTE LTD
BAXTER HEALTHCARE
(ASIA) PTE LTD
OMRON HEALTHCARE
SINGAPORE PTE LTD
MERCK PTE. LTD.
MEDTRONIC
INTERNATIONAL, LTD.
ABBOTT LABORATORIES
(SINGAPORE ) PRIVATE
LIMITED
TLCNB00015
TLCNB00015
TLCNB00015
TLCNB00015
TLCNB00015
TLCNB00015
TLCNB00015
TLCNB00015
TLCNB00015
TLCNB00015
TLCNB00016
MD11533707F
ABBOTT LABORATORIES
(SINGAPORE ) PRIVATE
LIMITED
TLCNB00016
TLCNB00017
MD11534025L
ALCON PTE LTD
TLCNB00017
TLCNB00018
MD11534263P
TLCNB00019
MD11534386I
MEDQUEST MARKETING
PTE LTD
LABQUIP ASIA PTE LTD
TLCNB00019
TLCNB00019
TLCNB00019
TLCNB00019
TLCNB00020
MD11534462G
ABBOTT LABORATORIES
(SINGAPORE ) PRIVATE
LIMITED
Device name submitted under
"Device Info" section in
MEDICS
MEDITECH EC-GO DIGITAL
HOLTER ECG SYSTEM
MEDITECH CARDIOTENS
AMBULATORY BLOOD
PRESSURE AND ECG
MONITOR
MEDITECH E-LITE PC-BASED
12-LEAD ECG SYSTEM
HS CODE
HSA Product Code
Remarks
90181100
HSAMDB01004
90181100
HSAMDB01004
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90181100
HSAMDB01004
REMOVED IN
VERSION 9
BOSTON SCIENTIFIC
90189090
JAGWIRE? GUIDEWIRES
STRYKER UROLOGY
90189030
HARDWARE - RIGID
CYSTOSCOPE
STRYKER UROLOGY
90189030
HARDWARE - RESECTOSCOPE
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REFER TO CRPNS
REMOVED IN
VERSION 9
STRYKER FLOCONTROL
ARTHROSCOPY PUMP
ALCON GRIESHABER?
REVOLUTION? DSP
BAXTER INTERLINK DUAL
LUER LOCK CAP
OMRON INSTANT EAR
THERMOMETER
SERONO EASYPOD?
AUTOINJECTOR
MEDTRONIC MC2X? THREESTAGE VENOUS CANNULA
ABBOTT CLINICAL CHEMISTRY
TOTAL PROTEIN ASSAY (LN
7D73 AND 1E65)
ABBOTT CLINICAL CHEMISTRY
ALBUMIN BCP ASSAY (LN 7D54
AND 1E65)
ABBOTT CLINICAL CHEMISTRY
TRIGLYCERIDE ASSAY (LN
7D74 AND 1E65)
ABBOTT CLINICAL CHEMISTRY
URIC ACID ASSAY (LN 7D76
AND 1E65)
ABBOTT CLINICAL CHEMISTRY
GLUCOSE ASSAY (LN 3L82
AND 1E65)
ABBOTT CLINICAL CHEMISTRY
ALBUMIN BCG ASSAY (LN 7D53
AND 1E65)
ABBOTT CLINICAL CHEMISTRY
UREA NITROGEN ASSAY (LN
7D75 AND 1E65)
90189030
REFER TO CRPNS
90185000
HSAMDB01008
90183990
HSAMDB01010
90251919
HSAMDB01004
90183910
HSAMDB01009
90183990
HSAMDB01010
38220090
HSAMDB01006
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
38220090
HSAMDB01006
REMOVED IN
VERSION 9
38220090
HSAMDB01006
REMOVED IN
VERSION 9
38220090
HSAMDB01006
REMOVED IN
VERSION 9
38220090
HSAMDB01006
REMOVED IN
VERSION 9
38220090
HSAMDB01006
REMOVED IN
VERSION 9
38220090
HSAMDB01006
REMOVED IN
VERSION 9
ABBOTT CLINICAL CHEMISTRY
CALCIUM ASSAY (LN 3L79 AND
1E65)
ABBOTT CLINICAL CHEMISTRY
PHOSPHORUS ASSAY (LN
7D71 AND 1E65)
ABBOTT CLINICAL CHEMISTRY
CREATININE ASSAY (LN 3L81
AND 1E65)
ABBOTT CLINICAL CHEMISTRY
CHOLESTEROL ASSAY (LN
7D62 AND 1E65)
ABBOTT ARCHITECT TOTAL T4
ASSAY (LN 7K66)
38220090
HSAMDB01006
REMOVED IN
VERSION 9
38220090
HSAMDB01006
REMOVED IN
VERSION 9
38220090
HSAMDB01006
REMOVED IN
VERSION 9
38220090
HSAMDB01006
REMOVED IN
VERSION 9
38220090
HSAMDB01006
REMOVED IN
VERSION 9
ABBOTT ARCHITECT FREE T4
ASSAY (LN 7K65)
ALCON I-KNIFE OPHTHALMIC
KNIFE
ALCON A-OK OPHTHALMIC
KNIFE
CARDINAL HEALTH MEDI-VAC?
SUCTION TUBING
PORTEX WALLACE OOCYTE
RECOVERY SET
PORTEX WALLACE
AMINOCENTESIS NEEDLE
PORTEX WALLACE DUAL
LUMEN OOCYTE RETRIEVAL
SET
PORTEX WALLACE DUAL
LUMEN OOCYTE RECOVERY
SET
PORTEX WALLACE OOCYTE
RECOVERY NEEDLE
ABBOTT ARCHITECT? INSULIN
ASSAY (LN 8K41)
38220090
HSAMDB01006
90185000
HSAMDB01008
90185000
HSAMDB01008
90183910
HSAMDB01010
90189090
HSAMDB01010
90183990
HSAMDB01010
90189090
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90189090
HSAMDB01010
38220090
HSAMDB01006
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
Page 5
REFER TO CRPNS
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
Device name submitted under HS CODE
"Device Info" section in
MEDICS
ABBOTT CLINICAL CHEMISTRY 38220090
LACTATE DEHYDROGENASE
ASSAY (LN 7D69 AND LN 2P56)
HSA Product Code
Remarks
TLCNB00021
MD11534638A
ABBOTT LABORATORIES
(SINGAPORE ) PRIVATE
LIMITED
HSAMDB01006
REMOVED IN
VERSION 9
TLCNB00022
MD11534719D
TRANSMEDIC PTE LTD
STERIS SYSTEM 1 STERILE
PROCESSING SYSTEM
STERIS AMSCO? CENTURY?
SMALL PREVACUUM STEAM
STERILIZERS
STERIS AMSCO? CENTURY?
MEDIUM STEAM STERILIZER
BOSTON SCIENTIFIC
PASSPORT? BALLOON ON A
WIRE DILATATION CATHETER
WITH HYDROPLUS COATING
38089490
HSAMDB01005
84192000
HSAMDB01005
REMOVED IN
VERSION 2
REMOVED IN
VERSION 9
TLCNB00023
MD11534729N
TRANSMEDIC PTE LTD
TLCNB00024
MD11534731P
TRANSMEDIC PTE LTD
TLCNB00025
MD11534949Z
BOSTON SCIENTIFIC ASIA
PACIFIC PTE. LTD.
84192000
HSAMDB01005
90183910
HSAMDB01010
TLCNB00026
MD11535100U
SMITH & NEPHEW PTE
LIMITED
SMITH & NEPHEW DIRECT
VIEW ARTHROSCOPES
(AUTOCLAVABLE)
ALCON PHARMACEUTICALS
SYSTANE ULTRA LUBRICANT
EYE DROPS
AESCULAP VENOSTRIP
DISPOSABLE VEIN
EXTIRPATION SET
AESCULAP INSITUCAT?
ATRAUMATIC VEIN VALVE
CUTTER
AESCULAP CUTFIX? SURGICAL
DISPOSABLE SCALPEL
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
TLCNB00027
MD11535175R
ALCON PTE LTD
30049099
REFER TO HPR
REMOVED IN
VERSION 9
TLCNB00028
MD11535226Q
B. BRAUN SINGAPORE PTE
LTD
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90189090
HSAMDB01009
REMOVED IN
VERSION 9
90189090
HSAMDB01009
REMOVED IN
VERSION 9
AESCULAP HISTOACRYL?
30061090
TISSUE ADHESIVE
ABBOTT ARCHITECT LH ASSAY 38220090
(LN 6C25 AND 7G94)
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
NAKANISHI SGR-E MICRO SAW 90184900
HANDPIECE AND BLADES
REFER TO CRPNS
REMOVED IN
VERSION 7
TLCNB00030
NAKANISHI SGT-E MICRO SAW 90184900
HANDPIECE AND BLADES
REFER TO CRPNS
REMOVED IN
VERSION 7
TLCNB00030
NAKANISHI STRAIGHT AND
90184100
GEARED ANGLE DENTAL
IMPLANT HANDPIECES
NAKANISHI SGO-E MICRO SAW 90184900
HANDPIECE AND BLADES
HSAMDB01003
REMOVED IN
VERSION 7
REFER TO CRPNS
REMOVED IN
VERSION 7
TLCNB00030
NAKANISHI TI-MAX INTERNAL
COOLANT CONTRA ANGLE
HANDPIECE TITANIUM BODY
90184100
HSAMDB01003
TLCNB00030
NAKANISHI EX SERIES
90184100
STRAIGHT AND CONTRA
ANGLE HANDPIECES
BAXTER CLEARLINK SYSTEM, 90183990
LUER ACTIVATED LOCK FOR IV
ACCESS, MALE LUER LOCK
ADAPTER
HSAMDB01003
HSAMDB01010
REMOVED IN
VERSION 9
MEDTRONIC OCTOPUS?
EVOLUTION
SMITHS MEDICAL PORTEX?
PERCUTANEOUS DILATION
TRACHEOSTOMY KIT WITH
SINGLE STAGE DILATOR, WITH
BLUE LINE ULTRA
TRACHEOSTOMY TUBE AND
INTRODUCER
FENWAL TRANSFER PACK
CONTAINER, WITH NEEDLE
ADAPTER
CORDIS MAXI LD? LARGE
DIAMETER BALLOON
PERCUTANEOUS
TRANSLUMINAL ANGIOPLASTY
(PTA) DILATATION CATHETER
90189090
HSAMDB01010
90192000
REFER TO CRPNS
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90183910
HSAMDB01010
REMOVED IN
VERSION 9
CORDIS POWERFLEX?
90183910
EXTREME PERCUTANEOUS
TRANSLUMINAL ANGIOPLASTY
CATHETER
CORDIS SAVVY?
90183910
PERCUTANEOUS
TRANSLUMINAL ANGIOPLASTY
(PTA) DILATATION CATHETER
HSAMDB01010
REMOVED IN
VERSION 9
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00028
TLCNB00028
TLCNB00028
TLCNB00029
MD11535274M
TLCNB00030
MD11536068A
ABBOTT LABORATORIES
(SINGAPORE ) PRIVATE
LIMITED
CHEE SANG DENTAL
SUPPLY PTE LTD
TLCNB00030
TLCNB00035
MD11536107N
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00036
MD11536222Y
TLCNB00037
MD11536266Q
MEDTRONIC
INTERNATIONAL, LTD.
IDS MEDICAL SYSTEMS
TLCNB00038
MD11536352Y
MEDQUEST MARKETING
PTE LTD
TLCNB00039
MD11536360G
JOHNSON & JOHNSON PTE
LTD
TLCNB00039
TLCNB00039
Page 6
HSAMDB01006
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
HSA Product Code
Remarks
HSAMDB01010
REMOVED IN
VERSION 9
HSAMDB01010
REMOVED IN
VERSION 9
COVIDIEN PRIVATE LIMITED USS AUTO SUTURE
90183990
BLUNTPORT? DISPOSABLE
TROCAR
COVIDIEN PRIVATE LIMITED USS AUTO SUTURE
90183990
VERSAPORT* V2 SINGLE USE
TROCAR AND SLEEVE WITH
SAFETY SHIELD
COVIDIEN PRIVATE LIMITED USS AUTO SUTURE VISIPORT* 90183990
PLUS OPTICAL TROCAR
HSAMDB01010
REMOVED IN
VERSION 9
HSAMDB01010
REMOVED IN
VERSION 9
HSAMDB01010
REMOVED IN
VERSION 9
COVIDIEN PRIVATE LIMITED USS AUTO SUTURE ENDO
DISSECT? SHORT
DISPOSABLE INSTRUMENT
WITH UNIPOLAR CAUTERY
COVIDIEN PRIVATE LIMITED USS AUTO SUTURE ENDO
SHEARS? SHORT DISPOSABLE
INSTRUMENT WITH UNIPOLAR
CAUTERY
ALCON PTE LTD
ALCON MONARCH? II/III IOL
DELIVERY SYSTEM
COVIDIEN PRIVATE LIMITED USS AUTO SUTURE
THORACOPORT SINGLE USE
TROCAR
MEDTRONIC
MEDTRONIC XOMED XPS?
INTERNATIONAL, LTD.
3000 POWERED ENT SYSTEM
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
90185000
HSAMDB01008
90183990
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
COVIDIEN PRIVATE LIMITED COVIDIEN ENDO CLINCH II
AUTOSUTURE SINGLE USE
INSTRUMENT
OCULUS PRIVATE LIMITED OCULUS FRESHKON
ALLURING EYES SOFT
CONTACT LENS
OCULUS FRESHKON GLITZI
SOFT CONTACT LENS
OCULUS FRESHKON COLORS
FUSION SPARKLERS SOFT
CONTACT LENS
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
90013000
HSAMDB01008
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
COVIDIEN PRIVATE LIMITED UNITED STATES SURGICAL
AUTOSUTURE? DST SERIES
EEA? ORVIL? DEVICE STAPLE
ANVIL ASSEMBLY
B. BRAUN SINGAPORE PTE B.BRAUN VASOFIX? SAFETY IV
LTD
CANNULA WITH INJECTION
PORT
OCULUS PRIVATE LIMITED OCULUS FRESHKON
ALLURING EYES 1-DAY
CONTACT LENS
OCULUS FRESHKON COLORS
FUSION 1-DAY CONTACT LENS
90189090
HSAMDB01009
REMOVED IN
VERSION 9
90183990
HSAMDB01010
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
TLCNB00055
OCULUS FRESHKON MOSAIC 1- 90013000
DAY CONTACT LENS
HSAMDB01008
REMOVED IN
VERSION 9
TLCNB00055
OCULUS FRESHKON DELIGHT
1-DAY CONTACT LENS
HSAMDB01008
REMOVED IN
VERSION 9
COVIDIEN PRIVATE LIMITED KENDALL KANGAROO?
90189030
ENTERAL FEEDING PUMPS
COVIDIEN PRIVATE LIMITED KENDALL KANGAROO?
90183990
ENTRISTAR SINGLE PASS
PERCUTANEOUS
ENDOSCOPIC GASTROSTOMY
(P.E.G.) KIT
COVIDIEN PRIVATE LIMITED KENDALL DOVER 100% LATEX- 90183910
FREE FOLEY CATHETERS
REFER TO CRPNS
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
HSAMDB01010
REMOVED IN
VERSION 11
COVIDIEN PRIVATE LIMITED KENDALL ENTRIFLEX
NASOGASTRIC FEEDING
TUBES
COVIDIEN PRIVATE LIMITED KENDALL GENUIUS TYMPANIC
THERMOMETER
COVIDIEN PRIVATE LIMITED KENDALL MAHURKAR DUAL
LUMEN CATHETERS AND
ACCESSORIES
COVIDIEN PRIVATE LIMITED KENDALL PEDI-TUBE FEEDING
TUBES
COVIDIEN PRIVATE LIMITED KENDALL QUINTON
PERITONEAL CATHETERS
SMITH & NEPHEW PTE
SMITH & NEPHEW DYONICS
LIMITED
LAPAROSCOPE
90183990
HSAMDB01010
REMOVED IN
VERSION 9
90251919
HSAMDB01004
90183910
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90183990
HSAMDB01010
90183910
HSAMDB01010
90181900
REFER TO CRPNS
TLCNB00039
TLCNB00039
TLCNB00041
MD11536610W
TLCNB00042
MD11536629P
TLCNB00043
MD11536646G
TLCNB00045
MD11536679N
TLCNB00046
MD11536690Y
TLCNB00047
MD11536697F
TLCNB00048
MD11536699H
TLCNB00049
MD11536704M
TLCNB00050
MD11536707P
TLCNB00051
MD11536715X
TLCNB00051
TLCNB00051
TLCNB00053
MD11536775F
TLCNB00054
MD11536782M
TLCNB00055
MD11536818W
TLCNB00055
TLCNB00057
MD11537086E
TLCNB00058
MD11537106Y
TLCNB00061
MD11537157X
TLCNB00062
MD11537173N
TLCNB00064
MD11537181V
TLCNB00065
MD11537195J
TLCNB00066
MD11537201P
TLCNB00067
MD11537206U
TLCNB00068
MD11537209X
Device name submitted under HS CODE
"Device Info" section in
MEDICS
CORDIS POWERFLEX? P3
90183910
PERCUTANEOUS
TRANSLUMINAL ANGIOPLASTY
CATHETER
CORDIS OPTA? PRO
90183910
PERIPHERAL TRANSLUMINAL
DILATATION (PTA) CATHETER
Page 7
90013000
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 10
REMOVED IN
VERSION 9
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
TLCNB00069
MD11537216E
COVIDIEN PRIVATE LIMITED
TLCNB00071
MD11537249L
COVIDIEN PRIVATE LIMITED
TLCNB00072
MD11537254Q
COVIDIEN PRIVATE LIMITED
TLCNB00073
MD11537273J
COVIDIEN PRIVATE LIMITED
TLCNB00073
TLCNB00073
TLCNB00073
TLCNB00073
TLCNB00073
TLCNB00074
MD11537285V
TLCNB00075
MD11537291B
TLCNB00075
TLCNB00075
TLCNB00075
TLCNB00075
TLCNB00076
MD11537305P
TLCNB00076
TLCNB00077
MD11537309T
TLCNB00077
TLCNB00077
TLCNB00078
MD11537316A
TLCNB00078
TLCNB00079
MD11537321F
TLCNB00079
TLCNB00079
TLCNB00079
TLCNB00080
MD11537338W
TLCNB00080
TLCNB00080
TLCNB00081
TLCNB00081
TLCNB00081
TLCNB00081
MD11537348G
Device name submitted under
"Device Info" section in
MEDICS
KENDALL ARGYLE SALEM
SUMPS
KENDALL MAHURKAR TRIPLE
LUMEN CATHETER
KENDALL QUINTON SINGLE
LUMEN CATHETER WITH
CURVED EXTENSIONS
KENDALL TANDEM-CATH 10 FR
CATHETER SYSTEM
KENDALL QUINTON RIGHT
ATRIAL CATHETERS AND
ACCESSORIES
KENDALL MAHURKAR 13.5 FR
CUFFED CATHETERS
KENDALL PERMCATH
CATHETERS AND
ACCESSORIES
KENDALL QUINTON
PERITONEAL DIALYSIS
CATHETER
KENDALL MAHURKAR MAXID
14.5 FR CUFFED CATHETER
HS CODE
HSA Product Code
Remarks
90183990
HSAMDB01010
90183910
HSAMDB01010
90183910
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90183910
HSAMDB01010
90183910
HSAMDB01010
90183910
HSAMDB01010
90183910
HSAMDB01010
90183910
HSAMDB01010
REMOVED IN
VERSION 9
90183910
HSAMDB01010
REMOVED IN
VERSION 9
MEDQUEST MARKETING
LONE STAR MEDICAL
PTE LTD
RETRACTOR SYSTEM
COVIDIEN PRIVATE LIMITED KENDALL CURAFIL HYDROGEL
GAUZE
KENDALL TELFA? AMD?
ANTIMICROBIAL NONADHERENT DRESSINGS
KENDALL EXCILON? AMD?
ANTIMICROBIAL DRAIN
SPONGES
KENDALL CURASORB
DRESSING
KENDALL KERLIX? AMD?
ANTIMICROBIAL GAUZE
BANDAGE ROLLS
COVIDIEN PRIVATE LIMITED KENDALL MONOJECT
HYPODERMIC NEEDLES
KENDALL MONOJECT
SUPRA/HONE BLOOD
COLLECTION NEEDLES
COVIDIEN PRIVATE LIMITED KENDALL DOVER URETHRAL
CATHETER TRAY
KENDALL ROBINSON CLEAR
VINYL URETHRAL 100% LATEX
FREE CATHETER
90189090
HSAMDB01009
30059090
HSAMDB01010
30059090
HSAMDB01010
REMOVED IN
VERSION 11
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
30059090
HSAMDB01010
REMOVED IN
VERSION 9
30051090
HSAMDB01010
30059090
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90183990
HSAMDB01010
90183990
HSAMDB01010
90183910
HSAMDB01010
90183910
HSAMDB01010
KENDALL DOVER ROB-NEL
100% LATEX FREE
CATHETERS
COVIDIEN PRIVATE LIMITED KENDALL CURITY SILICONE
COATED LATEX FOLEY
CATHETER
KENDALL KENGUARD
SILICONE-COATED FOLEY
CATHETERS
COVIDIEN PRIVATE LIMITED KENDALL MONOJECT CLEAR
LABEL BLOOD COLLECTION
TUBE
KENDALL MONOJECT CORVAC
MOTTLED STOPPER
90183910
HSAMDB01010
REMOVED IN
VERSION 9
90183910
HSAMDB01010
REMOVED IN
VERSION 11
90183910
HSAMDB01010
REMOVED IN
VERSION 11
90183990
HSAMDB01010
REMOVED IN
VERSION 11
90183990
HSAMDB01010
REMOVED IN
VERSION 11
KENDALL MONOJECT
SOFTPACK TUBERCULIN
SYRINGES
KENDALL MONOJECT
STANDARD BLOOD
COLLECTION TUBE
COVIDIEN PRIVATE LIMITED KENDALL CURAFIL GEL
WOUND DRESSING
KENDALL MOTHERMATES
HYDROGEL WOUND
DRESSING
KENDALL AQUAFLO
HYDROGEL WOUND
DRESSING
COVIDIEN PRIVATE LIMITED KENDALL DOBBHOFF NASO
JEJUNAL FEEDING/GASTRIC
DECOMPRESSION TUBE
KENDALL KANGAROO?
ENTRISTAR JEJUNAL
FEEDING/GASTRIC
DECOMPRESSION TUBE
KENDALL ENTRISTAR
ACCESSORIES
KENDALL ENTRISTAR SKIN
LEVEL ACCESSORIES
90183110
HSAMDB01010
REMOVED IN
VERSION 11
90183990
HSAMDB01010
REMOVED IN
VERSION 11
30059090
HSAMDB01010
30059090
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
30059090
HSAMDB01010
REMOVED IN
VERSION 9
90183990
HSAMDB01010
REMOVED IN
VERSION 11
90183990
HSAMDB01010
REMOVED IN
VERSION 11
90183990
HSAMDB01010
90183990
HSAMDB01010
REMOVED IN
VERSION 11
REMOVED IN
VERSION 11
Page 8
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
TLCNB00081
TLCNB00081
TLCNB00081
TLCNB00081
TLCNB00082
MD11537359R
TLCNB00082
TLCNB00083
MD11537371D
TLCNB00083
TLCNB00083
Device name submitted under HS CODE
"Device Info" section in
MEDICS
KENDALL DOBBHOFF
90183990
REPLACEMENT JEJUNAL TUBE
HSA Product Code
Remarks
HSAMDB01010
REMOVED IN
VERSION 11
KENDALL DOBBHOFF
90183990
NASOGASTRIC FEEDING
TUBES
KENDALL KANGAROO? ENDO- 90183990
TUBE? ENDOSCOPICALLY
PLACED FEEDING TUBE KIT
HSAMDB01010
REMOVED IN
VERSION 11
HSAMDB01010
REMOVED IN
VERSION 11
90183990
HSAMDB01010
REMOVED IN
VERSION 11
90183990
HSAMDB01010
30059090
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
KENDALL ARGYLE AQUA-SEAL 90189030
CHEST DRAINAGE UNIT
REFER TO CRPNS
REMOVED IN
VERSION 9
KENDALL KANGAROO?
DOBBHOFF JEJUNAL
FEEDING/GASTRIC
DECOMPRESSION SYSTEM
COVIDIEN PRIVATE LIMITED KENDALL ANGLE WING BLOOD
COLLECTION SET
KENDALL OWENS NONADHERENT SURGICAL
DRESSING
COVIDIEN PRIVATE LIMITED KENDALL ARGYLE ALTITUDE
DRY SUCTION CHEST
DRAINAGE UNIT
KENDALL ARGYLE SENTINEL
SEAL CHEST DRAINAGE UNIT
TLCNB00084
MD11537378K
COVIDIEN PRIVATE LIMITED KENDALL-LTP SAFELINC?
FETAL SPIRAL ELECTRODES
(FSE) SYSTEM
90181900
REFER TO CRPNS
REMOVED IN
VERSION 9
TLCNB00085
MD11537428I
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
TLCNB00086
MD11537430K
90183910
HSAMDB01010
TLCNB00087
MD11537433N
90183910
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
TLCNB00088
MD11537435P
90183910
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00089
MD11537437R
90183990
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00090
MD11537440U
90183990
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00091
MD11537445Z
90183110
HSAMDB01010
TLCNB00092
MD11537449D
30051090
HSAMDB01010
TLCNB00093
MD11537459N
90189030
REFER TO CRPNS
TLCNB00094
MD11537613L
90200000
HSAMDB01002
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
TLCNB00095
MD11537627Z
90200000
HSAMDB01002
TLCNB00096
MD11537634G
COVIDIEN PRIVATE LIMITED KENDALL KANGAROO?
ENTRIFLUSH? ENTERNAL
FEEDING PUMP
COVIDIEN PRIVATE LIMITED KENDALL ARGYLE THORACIC
CATHETERS
COVIDIEN PRIVATE LIMITED KENDALL DOVER SILICONE
ELASTOMER-COATED LATEX
FOLEY CATHETERS
COVIDIEN PRIVATE LIMITED KENDALL FAST-CATH FEMALE
URETHRAL CATHETERIZATION
KIT
COVIDIEN PRIVATE LIMITED KENDALL MONOJECT BONE
MARROW BIOPSY NEEDLES
AND TRAYS
COVIDIEN PRIVATE LIMITED KENDALL MONOJECT
LIFESHIELD BLUNT
NEEDLES/CANNULA
COVIDIEN PRIVATE LIMITED KENDALL MONOJECT SAFETY
SYRINGES
COVIDIEN PRIVATE LIMITED KENDALL POLYSKIN II
TRANSPARENT DRESSING
COVIDIEN PRIVATE LIMITED KENDALL SCD RESPONSE
COMPRESSION SYSTEM
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT
LASER ORAL TRACHEAL TUBE
CUFFLESS
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT HILO? TRACHEAL TUBE
OCULUS PRIVATE LIMITED OCULUS FRESHKON SOFT
CONTACT LENS
OCULUS FRESHKON TORIC
SOFT CONTACT LENS
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT HICONTOUR ORAL/NASAL
TRACHEAL TUBE BRANDT
SYSTEM
CLEARLAB SG PTE. LTD.
CLEAR 55A METHAFILCON A
SOFT SPHERICAL CONTACT
LENS FOR DAILY WEAR
90013000
HSAMDB01008
90013000
HSAMDB01008
90200000
HSAMDB01002
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
TLCNB00096
TLCNB00097
MD11537637J
TLCNB00098
MD11537639L
TLCNB00098
TLCNB00098
TLCNB00098
TLCNB00098
CLEARLAB CLEAR? 55A
METHAFILCON A SOFT
SPHERICAL CONTACT LENS
FOR DAILY WEAR
CLEARLAB CLEAR? 1-DAY
HIOXIFILCON SOFT
SPHERICAL CONTACT LENS
CLEARLAB CLEAR? 1-DAY
HIOXIFILCON SOFT
(HYDROPHILIC) SPHERICAL
CONTACT LENS
CLEAR ALL DAY HIOXIFILCON
A SOFT (HYDROPHILIC)
SPHERICAL CONTACT LENS
Page 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
TLCNB00098
TLCNB00098
TLCNB00098
TLCNB00098
TLCNB00098
TLCNB00098
TLCNB00098
TLCNB00098
TLCNB00098
Device name submitted under
"Device Info" section in
MEDICS
CLEARLAB CLEAR? 55
METHAFILCON A SOFT
SPHERICAL CONTACT LENS
FOR DAILY WEAR
CLEARLAB CLEAR? ALL-DAY
HIOXIFILCON A SOFT
(HYDROPHILIC) SPHERICAL
CONTACT LENS
CLEARLAB CLEAR? ALL-DAY T
HIOXIFILCON A SOFT
(HYDROPHILIC) TORIC
CONTACT LENS
CLEARLAB CLEAR? 38
POLYMACON SOFT
(HYDROPHILIC) SPHERICAL
CONTACT LENS
CLEARLAB AQUASOFT?
ETAFILCON A SOFT
SPHERICAL CONTACT LENS
FOR DAILY WEAR
CLEARLAB? 55 UV
METHAFILCON A SOFT
SPHERICAL CONTACT LENS
FOR DAILY WEAR
CLEARLAB CLEAR? 58
ETAFILCON A SOFT
SPHERICAL CONTACT LENS
FOR DAILY WEAR
CLEARLAB? 38 POLYMACON
SOFT (HYDROPHILIC)
SPHERICAL CONTACT LENS
HS CODE
HSA Product Code
Remarks
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
CLEAR 58 ETAFILCON A SOFT 90013000
SPHERICAL CONTACT LENS
FOR DAILY WEAR
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT LO- 90200000
CONTOUR ORAL/NASAL
TRACHEAL TUBE
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT HI- 90200000
LO ORAL/NASAL TRACHEAL
TUBE/LANZ SYSTEM
HSAMDB01008
REMOVED IN
VERSION 9
HSAMDB01002
REMOVED IN
VERSION 9
HSAMDB01002
REMOVED IN
VERSION 9
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT
90200000
LASER ORAL/NASAL
TRACHEAL TUBE DUAL
CUFFED
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT HI- 90200000
CONTOUR ORAL/NASAL
TRACHEAL TUBE CUFFED
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT LO- 90200000
CONTOUR TRACHEAL TUBE
HSAMDB01002
REMOVED IN
VERSION 9
HSAMDB01002
REMOVED IN
VERSION 9
HSAMDB01002
REMOVED IN
VERSION 9
TLCNB00099
MD11537660G
TLCNB00100
MD11537666M
TLCNB00101
MD11537674U
TLCNB00102
MD11537723R
TLCNB00103
MD11537734C
TLCNB00104
MD11537740I
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT HILO ORAL/NASAL TRACHEAL
TUBE/MURPHY EYE
90200000
HSAMDB01002
REMOVED IN
VERSION 9
TLCNB00105
MD11537763F
HSAMDB01002
REMOVED IN
VERSION 11
TLCNB00106
MD11537778U
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT LO 90200000
CONTOUR ORAL/NASAL
TRACHEAL TUBE
REINFORCED/BRANDT
SYSTEM
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT
90200000
ORAL/NASAL RAE TRACHEAL
TUBE CUFFLESS MURPHY EYE
HSAMDB01002
REMOVED IN
VERSION 9
TLCNB00107
MD11537786C
HSAMDB01002
REMOVED IN
VERSION 9
TLCNB00108
MD11537794K
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT
90200000
RAE TRACHEAL TUBE
CUFFED/BRANDT SYSTEM
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT
90200000
DOUBLE SWIVEL CONNECTOR
HSAMDB01002
REMOVED IN
VERSION 9
TLCNB00109
MD11537838C
90192000
REFER TO CRPNS
TLCNB00110
MD11537842G
90200000
HSAMDB01002
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
TLCNB00111
MD11537846K
90200000
HSAMDB01002
REMOVED IN
VERSION 9
TLCNB00112
MD11537857V
90200000
HSAMDB01002
REMOVED IN
VERSION 9
TLCNB00113
MD11537947H
90192000
REFER TO CRPNS
REMOVED IN
VERSION 9
TLCNB00114
MD11537965Z
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT
NASOPHARYNGEAL AIRWAY
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT
ORAL/NASAL TRACHEAL TUBE
MURPHY EYE
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT
MLT? MICROLARYNGEAL
TRACHEAL TUBE
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT
OXFORD ORAL TRACHEAL
TUBE CUFFED
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT
ESOPHAGEAL TRACHEAL
AIRWAY
COVIDIEN PRIVATE LIMITED COVIDIEN SHILEY
TRACHEOSTOMY TUBE XLT
W/DISPOSABLE INNER
CANNULA
90192000
REFER TO CRPNS
REMOVED IN
VERSION 9
Page 10
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
TLCNB00115
MD11537996E
COVIDIEN PRIVATE LIMITED
TLCNB00116
MD11538001J
TLCNB00117
MD11538042Y
BAXTER HEALTHCARE
(ASIA) PTE LTD
COVIDIEN PRIVATE LIMITED
TLCNB00118
MD11538052I
COVIDIEN PRIVATE LIMITED
TLCNB00119
MD11538069Z
COVIDIEN PRIVATE LIMITED
TLCNB00120
MD11538085P
COVIDIEN PRIVATE LIMITED
TLCNB00121
MD11538093X
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00122
MD11538097B
COVIDIEN PRIVATE LIMITED
TLCNB00123
MD11538186M
TLCNB00124
MD11538310G
BAXTER HEALTHCARE
(ASIA) PTE LTD
SMITH & NEPHEW PTE
LIMITED
TLCNB00125
MD11538314K
TLCNB00126
MD11538335F
TLCNB00127
MD11538351V
TLCNB00128
MD11538361F
TLCNB00129
MD11538370O
B. BRAUN SINGAPORE PTE
LTD
TLCNB00130
MD11538676I
TLCNB00131
MD11538694A
TLCNB00132
MD11538751F
TLCNB00133
MD11538754I
TLCNB00134
MD11538756K
TLCNB00135
MD11538825B
TLCNB00136
MD11538979Z
TLCNB00137
MD11538988I
TLCNB00138
MD11538992M
TLCNB00139
MD11538997R
TLCNB00140
MD11539005Z
TLCNB00141
MD11539008C
TLCNB00142
MD11539036E
TLCNB00143
MD11539131V
TLCNB00144
MD11539138C
IDS MEDICAL SYSTEMS
TLCNB00145
MD11539161Z
TLCNB00145
Device name submitted under
"Device Info" section in
MEDICS
COVIDIEN SHILEY PITT
TRACHEOSTOMY TUBE
CUFFED
BAXTER BLOOD
ADMINISTRATION SET
COVIDIEN MALLINCKRODT
WARMTOUCH? CAREQUILT?
BLANKET
COVIDIEN WARMTOUCH?
WARMING UNIT &
ACCESSORIES
COVIDIEN MON-A-THERM?
FOLEY CATHETER WITH
TEMPERATURE PROBE
COVIDIEN MON-A-THERM?
OESOPHAGEAL
STETHOSCOPE WITH
TEMPERATURE SENSOR
BAXTER BURETROL I.V.
SOLUTION ADMINISTRATION
SET
COVIDIEN MON-A-THERM?
GENERAL PURPOSE
TEMPERATURE PROBE
BAXTER BLOOD
ADMINISTRATION PUMP SET
SMITH & NEPHEW DYONICS 25
FLUID MANAGEMENT SYSTEM
HS CODE
HSA Product Code
Remarks
90192000
REFER TO CRPNS
REMOVED IN
VERSION 9
90189020
HSAMDB01010
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
REMOVED IN
VERSION 11
90189030
REFER TO CRPNS
REMOVED IN
VERSION 11
90183910
HSAMDB01010
REMOVED IN
VERSION 11
90181900
REFER TO CRPNS
REMOVED IN
VERSION 11
90189020
HSAMDB01010
REMOVED IN
VERSION 9
90251919
HSAMDB01010
REMOVED IN
VERSION 9
90189020
HSAMDB01010
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
SMITH & NEPHEW PINS AND
WIRES
OLYMPUS? OES
CHOLEDOCHOFIBERSCOPE
GIVEN DIAGNOSTIC SYSTEM
90189090
HSAMDB01010
90189030
REFER TO CRPNS
90063000
HSAMDB01004
BAXTER SOLUTION
ADMINISTRATION SET
VENTED, WITH 1 INJECTION
SITE
B. BRAUN ANGIODYN? GUIDE
WIRES, PTFE-COATED
90189020
HSAMDB01010
90189090
HSAMDB01010
REMOVED IN
VERSION 9
COVIDIEN PRIVATE LIMITED COVIDIEN MON-A-THERM?
SKIN TEMPERATURE PROBE
90251919
HSAMDB01010
REMOVED IN
VERSION 9
COVIDIEN PRIVATE LIMITED COVIDIEN MON-A-THERM?
TYMPANIC TEMPERATURE
PROBE
B. BRAUN SINGAPORE PTE B. BRAUN INTROCAN?
LTD
SAFETY? I.V. CANNULA
ABBOTT LABORATORIES
ABBOTT FLEXIFLO ENTERAL
(SINGAPORE ) PRIVATE
FEEDING TUBE
LIMITED
BAXTER HEALTHCARE
BAXTER INTERLINK
(ASIA) PTE LTD
EXTENSION SET WITH FILTER
90251919
HSAMDB01010
REMOVED IN
VERSION 9
90189020
HSAMDB01010
90183990
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90183990
HSAMDB01010
REMOVED IN
VERSION 9
UNISON COLLABORATIVE
Q-MED DEFLUX? METAL
PTE. LTD.
NEEDLE
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT
WARMTOUCH? CAREDRAPE?
BLANKET
STRYKER SINGAPORE
STRYKER GAMMA 3 NAIL
PRIVATE LIMITED
SYSTEM (INSTRUMENTS)
COVIDIEN PRIVATE LIMITED KENDALL ARGYLE AERO-FLO
SUCTION CATHETERS
COVIDIEN PRIVATE LIMITED COVIDIEN FEEDING TUBES
90183990
HSAMDB01010
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90189090
HSAMDB01009
90183910
HSAMDB01010
90183990
HSAMDB01010
COVIDIEN PRIVATE LIMITED COVIDIEN KANGAROO?
FEEDING TUBE
COVIDIEN PRIVATE LIMITED KENDALL YANKAUER
SURGICAL SUCTION
INSTRUMENT
PHILIPS ELECTRONICS
PHILIPS PAGEWRITER TC30
SINGAPORE PTE LTD
CARDIOGRAPH
SMITH & NEPHEW PTE
SMITH & NEPHEW CLEARLIMITED
TRAC DISPOSABLE CANNULA
WITH OBTURATOR
90183990
HSAMDB01010
90183990
HSAMDB01010
90181100
HSAMDB01004
90183990
HSAMDB01010
SMITHS MEDICAL PORTEX
90200000
POLAR PREFORMED
TRACHEAL TUBES, UNCUFFED
HSAMDB01002
REMOVED IN
VERSION 9
BARD SINGAPORE PTE LTD BARD NAVARRE? OPTI-DRAIN? 90183910
MULTI-USE DRAINAGE
CATHETER
BARD NAVARRE? UNIVERSAL 90183910
DRAINAGE CATHETER WITH
NITINOL
HSAMDB01010
REMOVED IN
VERSION 9
HSAMDB01010
REMOVED IN
VERSION 9
SMITH & NEPHEW PTE
LIMITED
OLYMPUS SINGAPORE PTE
LTD
SERVICOM MEDICAL
(SINGAPORE) PTE LTD
BAXTER HEALTHCARE
(ASIA) PTE LTD
Page 11
REMOVED IN
VERSION 9
REMOVED IN
VERSION 11
REMOVED IN
VERSION 11
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 11
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
HS CODE
HSA Product Code
Remarks
TLCNB00146
MD11539211X
E-XCLUSIF MEDICAL
SUPPLY PTE. LTD.
30051090
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00147
MD11539232S
SMITH & NEPHEW PTE
LIMITED
SMITH & NEPHEW
90189090
DISPOSABLE BLADES AND
BURRS
BD VACUTAINER? FLASHBACK 90183990
BLOOD COLLECTION NEEDLE
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00148
MD11539240A
BECTON DICKINSON
MEDICAL (S) PTE LTD
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00149
MD11539251L
COVIDIEN PRIVATE LIMITED COVIDIEN SHILEY NEONATAL
AND PAEDIATRIC
TRACHEOSTOMY TUBE
CUFFLESS & ACCESSORIES
90192000
REFER TO CRPNS
REMOVED IN
VERSION 11
TLCNB00150
MD11539266A
COVIDIEN PRIVATE LIMITED KENDALL 60CC PISTON/BULB
IRRIGATION TRAYS
90189090
HSAMDB01005
REMOVED IN
VERSION 9
TLCNB00151
MD11539269D
COVIDIEN PRIVATE LIMITED COVIDIEN SHILEY
90192000
TRACHEOSTOMY CANNULAE
WITH DISPOSABLE CANNULA &
ACCESSORIES
REFER TO CRPNS
REMOVED IN
VERSION 9
TLCNB00152
MD11539275J
COVIDIEN PRIVATE LIMITED COVIDIEN SHILEY
90192000
TRACHEOSTOMY TUBE
CUFFLESS WITH DISPOSABLE
INNER CANNULA &
ACCESSORIES
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT
90200000
ENDOBRONCHIAL TUBE
COVIDIEN PRIVATE LIMITED COVIDIEN SHILEY CUFFLESS
90192000
TRACHEOSTOMY TUBES &
ACCESSORIES
REFER TO CRPNS
REMOVED IN
VERSION 9
TLCNB00153
MD11539310S
HSAMDB01002
REMOVED IN
VERSION 11
REMOVED IN
VERSION 9
TLCNB00154
MD11539320C
TLCNB00158
MD11539364U
COVIDIEN PRIVATE LIMITED COVIDIEN SHILEY
90192000
TRACHEOSTOMY TUBE
CUFFED WITH INNER
CANNULA & ACCESSORIES
MEDQUEST MARKETING
FENWAL ANTICOAGULANT
90183990
PTE LTD
CITRATE PHOSPHATE
DEXTROSE SOLUTION, USP
(CPD) BLOOD-PACK? UNITS
EDGE MEDITRONICS PTE.
COEUR DISPOSABLE CT/MR
90183110
LTD.
AND ANGIOGRAPHIC SYRINGE
FOR NEMOTO INJECTORS
WITH ACCESSORIES
REFER TO CRPNS
REMOVED IN
VERSION 9
TLCNB00159
MD11539369Z
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00160
MD11539401F
HSAMDB01010
REMOVED IN
VERSION 11
TLCNB00161
MD11539405J
SYNTHES SINGAPORE PTE. SYNTHES? COLIBRI COMPACT 90189030
LTD.
LIGHT BATTERY DRILL
REFER TO CRPNS
REMOVED IN
VERSION 9
TLCNB00162
MD11539571T
COVIDIEN PRIVATE LIMITED KENDALL CURITY STRAIGHT
URETHRAL CATHETERS
KENDALL CURITY FEEDING
TUBE
COVIDIEN PRIVATE LIMITED KENDALL VIASORB
ABSORBENT DRESSING
COVIDIEN PRIVATE LIMITED KENDALL CURASALT SODIUM
CHLORIDE DRESSING
90183910
HSAMDB01010
90183990
HSAMDB01010
30059090
HSAMDB01010
30059090
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
KENDALL CURITY? AMD?
ANTIMICROBIAL GAUZE
SPONGES
KENDALL CURITY NONADHERENT DRESSING
COVIDIEN PRIVATE LIMITED KENDALL PEDIATRIC URINE
COLLECTORS
COVIDIEN PRIVATE LIMITED KENDALL VASELINE
PETROLATUM GAUZE
JOHNSON & JOHNSON PTE CODMAN? MALIS?
LTD
INTEGRATED IRRIGATION
TUBING AND BIPOLAR CORD
SET
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT
RAE TRACHEAL TUBE CUFFED
30059090
HSAMDB01010
REMOVED IN
VERSION 9
30059090
HSAMDB01010
90189090
HSAMDB01010
30059020
HSAMDB01010
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 11
90200000
HSAMDB01002
REMOVED IN
VERSION 9
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT
ORAL/NASAL REINFORCED
TRACHEAL TUBE
COVIDIEN PRIVATE LIMITED MALLINCKRODT HI-LO? EVAC
ENDOTRACHEAL TUBE
90200000
HSAMDB01002
REMOVED IN
VERSION 9
90200000
HSAMDB01002
REMOVED IN
VERSION 11
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT LO- 90200000
CONTOUR ORAL/NASAL
TRACHEAL TUBE CUFFED,
MAGILL TIP
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT LO- 90200000
CONTOUR ORAL/NASAL
TRACHEAL TUBE CUFFED,
MURPHY EYE
HSAMDB01002
REMOVED IN
VERSION 11
HSAMDB01002
REMOVED IN
VERSION 9
TLCNB00162
TLCNB00163
MD11539575X
TLCNB00164
MD11539607D
TLCNB00164
TLCNB00164
TLCNB00165
MD11539618O
TLCNB00166
MD11539639J
TLCNB00167
MD11539660E
TLCNB00168
MD11539684C
TLCNB00169
MD11539698Q
TLCNB00170
MD11539714G
TLCNB00171
MD11539717J
TLCNB00172
MD11539729V
Device name submitted under
"Device Info" section in
MEDICS
MEDLOGIC LIQUIBAND? AND
LIQUIBAND FLOW CONTROL?
TISSUE ADHESIVE
Page 12
REFER TO CRPNS
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
HS CODE
HSA Product Code
Remarks
TLCNB00173
MD11539771L
Device name submitted under
"Device Info" section in
MEDICS
THERMAL INTERNATIONAL CINCINNATI WARMAIR
(S) PTE. LTD.
CONVECTIVE AIR THERAPY
SYSTEM
CINCINNATI NORM-O-TEMP?
TOTAL BODY HYPERTHERMIA
SYSTEM
CINCINNATI BLANKETROL? II
HYPER-HYPOTHERMIA WATER
SYSTEM
COVIDIEN PRIVATE LIMITED KENDALL FILAC FASTEMP
ELECTRONIC THERMOMETER
90189030
REFER TO CRPNS
REMOVED IN
VERSION 11
90189030
REFER TO CRPNS
REMOVED IN
VERSION 11
90189030
REFER TO CRPNS
REMOVED IN
VERSION 11
90251919
HSAMDB01004
REMOVED IN
VERSION 9
SOMNOTEC (S) PTE. LTD.
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90189090
HSAMDB01010
REMOVED IN
VERSION 9
HSAMDB01010
REMOVED IN
VERSION 9
STRYKER SINGAPORE
PRIVATE LIMITED
COOK SOUTH EAST ASIA
PTE LTD
BOSTON SCIENTIFIC NAMIC?
90183990
PRESSURE MONITORING
LINES
STRYKER MIXEVAC3 BONE
90189030
CEMENT MIXER
COOK BENCHTOP INCUBATOR 90189030
& HUMIDIFICATION FLASK
REFER TO CRPNS
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
COOK REGULATED VACUUM
PUMP & FOOT PEDAL
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
TLCNB00173
TLCNB00173
TLCNB00176
MD11539804S
TLCNB00177
MD11539812A
TLCNB00177
TLCNB00177
BOSTON SCIENTIFIC NAMIC?
OPTION 125? Y-ADAPTOR
PRODUCTS
BOSTON SCIENTIFIC NAMIC?
ANGIOGRAPHIC MANIFOLDS
TLCNB00178
MD11539849L
TLCNB00179
MD11539887X
TLCNB00180
MD11539894E
COOK SOUTH EAST ASIA
PTE LTD
TLCNB00181
MD11539914Y
COVIDIEN PRIVATE LIMITED MALLINCKRODT
LAVACUATOR? GASTRIC
LAVAGE TUBE
MALLINCKRODT VENTROL?
DOUBLE LUMEN GASTRODUODENAL TUBE
MALLINCKRODT THORACIC
CATHETER
COVIDIEN PRIVATE LIMITED COVIDIEN DAR? APL VALVE
BREATHING SYSTEM
COVIDIEN PRIVATE LIMITED MALLINCKRODT DAR? ADULTPEDIATRIC MECHANICAL
FILTER HME
COVIDIEN PRIVATE LIMITED MALLINCKRODT DAR? ADULTPEDIATRIC HME
COVIDIEN PRIVATE LIMITED MALLINCKRODT DAR? MANUAL
BREATHING UNIT (MBU)
90183990
HSAMDB01004
REMOVED IN
VERSION 9
90183990
HSAMDB01004
REMOVED IN
VERSION 9
90183910
HSAMDB01010
90192000
REFER TO CRPNS
84213990
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90192000
REFER TO CRPNS
90192000
REFER TO CRPNS
TLCNB00181
TLCNB00181
REFER TO CRPNS
TLCNB00183
MD11539962U
TLCNB00184
MD11539964W
TLCNB00185
MD11539966Y
TLCNB00186
MD11539968A
TLCNB00187
MD11539970C
COVIDIEN PRIVATE LIMITED MALLINCKRODT DAR? PEEP
VALVE BREATHING SYSTEM
90192000
REFER TO CRPNS
REMOVED IN
VERSION 9
TLCNB00188
MD11539985R
REFER TO CRPNS
REMOVED IN
VERSION 9
TLCNB00189
MD11539993Z
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00190
MD11539998E
COVIDIEN PRIVATE LIMITED MALLINCKRODT DAR? ADULT- 90192000
PEDIATRIC FOAM HME WITH
INTEGRATED CATHETER
MOUNT
COVIDIEN PRIVATE LIMITED MALLINCKRODT DAR?
90183910
SECRETION REMOVER FOR
ENDOTRACHEAL TUBE AND
TRACHEOSTOMY TUBE
COVIDIEN PRIVATE LIMITED MALLINCKRODT DAR? HEAT
90192000
AND MOISTURE EXCHANGER
FOR TRACHEOSTOMIZED
PATIENTS
REFER TO CRPNS
REMOVED IN
VERSION 9
TLCNB00191
MD11540020A
COVIDIEN PRIVATE LIMITED COVIDIEN DAR?
TRANSLARYNGEAL
TRACHEOSTOMY TLT KIT SET
90183990
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00192
MD11540022C
84213990
HSAMDB01010
TLCNB00193
MD11540024E
COVIDIEN PRIVATE LIMITED COVIDIEN DAR?
ELECTROSTATIC FILTER
COVIDIEN PRIVATE LIMITED COVIDIEN DAR? SHILEY
PHONATE? SPEAKING VALVE
90192000
REFER TO CRPNS
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
TLCNB00194
MD11540027H
COVIDIEN PRIVATE LIMITED COVIDIEN DAR TLT SET
90192000
REFER TO CRPNS
TLCNB00195
MD11540029J
84213990
HSAMDB01002
TLCNB00196
MD11540036Q
90181200
REFER TO CRPNS
REMOVED IN
VERSION 9
TLCNB00197
MD11540041V
90013000
HSAMDB01008
REMOVED IN
VERSION 9
TLCNB00198
MD11540075D
90183990
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00202
MD11540159J
COVIDIEN PRIVATE LIMITED COVIDIEN DAR ADULTPEDIATRIC MECHANICAL
FILTER HME
BARD SINGAPORE PTE LTD BARD ACCESS SYSTEMS
SITE~RITE* 5 ULTRASOUND
SYSTEM
CIBA VISION (SINGAPORE) CIBA VISION DAILIES?
PTE LTD
FRESHLOOK? ILLUMINATE
ONE-DAY COLOR CONTACT
LENSES
COOK SOUTH EAST ASIA
COOK X-REIDY BREAST
PTE LTD
LESION LOCALIZATION
NEEDLE
COVIDIEN PRIVATE LIMITED COVIDIEN DAR? NASAL
CANNULA
90183990
HSAMDB01002
REMOVED IN
VERSION 9
Page 13
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
Device name submitted under
"Device Info" section in
MEDICS
COVIDIEN PRIVATE LIMITED COVIDIEN TY-CARE EXCEL
CLOSED SYSTEM FOR
TRACHEOBRONCHIAL/ENDOTRACHEAL
SUCTION
JOHNSON & JOHNSON PTE CORDIS AVANTI?+ CATHETER
LTD
SHEATH INTRODUCER
HS CODE
HSA Product Code
Remarks
TLCNB00203
MD11540161L
90183910
HSAMDB01010
REMOVED IN
VERSION 11
TLCNB00206
MD11540180E
90183910
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00207
MD11540258E
SERONO REBIJECT? II
90183110
AUTOINJECTOR
SERONO ONE.CLICK? NEEDLE 90183990
HSAMDB01010
SERONO ONE.CLICK?
AUTOINJECTOR
SERONO EASYPOD?
AUTOINJECTOR
CSS PERFUSION TUBING SET
90183110
HSAMDB01010
90183910
HSAMDB01009
90183990
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
MERCK PTE. LTD.
TLCNB00207
TLCNB00207
TLCNB00207
HSAMDB01010
TLCNB00208
MD11540306A
CONTRACT STERILIZATION
SERVICES PTE LTD
TLCNB00209
MD11540333B
WELCH ALLYN SINGAPORE WELCH ALLYN? ABPM 6100
PTE. LTD.
AMBULATORY BLOOD
PRESSURE MONITORING
SYSTEM
WELCH ALLYN? SURETEMP?
PLUS THERMOMETER
90181900
REFER TO CRPNS
REMOVED IN
VERSION 9
90251919
HSAMDB01004
REMOVED IN
VERSION 9
STRYKER SINGAPORE
PRIVATE LIMITED
MEDQUEST MARKETING
PTE LTD
BIO-RAD LABORATORIES
(SINGAPORE) PTE LTD
E-XCLUSIF MEDICAL
SUPPLY PTE. LTD.
90189090
HSAMDB01009
90189090
HSAMDB01009
38220090
HSAMDB01006
90192000
REFER TO CRPNS
REMOVED IN
VERSION 9
REMOVED IN
VERSION 11
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90192000
REFER TO CRPNS
REMOVED IN
VERSION 9
90192000
REFER TO CRPNS
REMOVED IN
VERSION 9
90192000
REFER TO CRPNS
REMOVED IN
VERSION 9
90183910
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00209
TLCNB00210
MD11540368K
TLCNB00213
MD11540738Q
TLCNB00214
MD11540798Y
TLCNB00215
MD11540891N
TLCNB00215
TLCNB00215
TLCNB00215
STRYKER ACCOLADE SYSTEM
INSTRUMENTATION
FENWAL CPD/SAG-M QUAD
OPTIPAC
BIO-RAD IN2IT A1C TEST
SYSTEM
CLEMENT CLARKE MEDIX
WORLD TRAVELLER
COMPRESSOR NEBULISER HIFLO
CLEMENT CLARKE MEDIX
TURBONEB COMPRESSOR
NEBULISER
CLEMENT CLARKE MEDIX HIFLO COMPRESSOR
NEBULISER
CLEMENT CLARKE MEDIX
ECONONEB COMPRESSOR
NEBULISER
CORDIS BRITE TIP CATHETER
SHEATH INTRODUCER
TLCNB00217
MD11541152O
JOHNSON & JOHNSON PTE
LTD
TLCNB00218
MD11541184U
90189030
REFER TO CRPNS
REMOVED IN
VERSION 11
TLCNB00219
MD11541189Z
COVIDIEN PRIVATE LIMITED KENDALL ARGYLE YANKAUER
SELEC-TROL SUCTION
INSTRUMENTS
COVIDIEN PRIVATE LIMITED KENDALL CURITY RED
RUBBER CATHETERS
KENDALL ULTRAMER FOLEY
CATHETERS
KENDALL ULTRAMER FOLEY
CATHETER KIT
KENDALL DOVER RED RUBBER
ROBINSON CATHETERS
90183910
HSAMDB01010
90183910
HSAMDB01010
90183910
HSAMDB01010
90183910
HSAMDB01010
REMOVED IN
VERSION 11
REMOVED IN
VERSION 11
REMOVED IN
VERSION 11
REMOVED IN
VERSION 11
ALPHA-HEALTH (ASIA) PTE
LTD
OLYMPUS SINGAPORE PTE
LTD
JMS SINGAPORE PTE LTD
SILIMED NOSTRIL RETAINER
90219000
HSAMDB01007
OLYMPUS? EVIS LUCERA
ENDOSCOPY SYSTEM
JMS EXTENSION TUBE
90189030
REFER TO CRPNS
90189020
HSAMDB01010
BECTON DICKINSON
MEDICAL (S) PTE LTD
JOHNSON & JOHNSON PTE
LTD
BOSTON SCIENTIFIC ASIA
PACIFIC PTE. LTD.
BD INSYTE? I.V. CATHETER
90183910
HSAMDB01010
CODMAN RETRACTORS
90189090
HSAMDB01009
BOSTON SCIENTIFIC BACK-UP 90189090
MEIER STEERABLE GUIDE
WIRE
CODMAN RETRACTORS
90189090
HSAMDB01010
TLCNB00219
TLCNB00219
TLCNB00219
TLCNB00220
MD11541272E
TLCNB00221
MD11541391T
TLCNB00222
MD11541401D
TLCNB00223
MD11541418U
TLCNB00224
MD11541548U
TLCNB00225
MD11541550W
TLCNB00226
MD11541552Y
TLCNB00227
MD11541699P
TLCNB00228
MD11541789B
TLCNB00229
MD11541813Z
TLCNB00230
MD11541879N
TLCNB00231
MD11541986Q
TLCNB00232
MD11541998C
JOHNSON & JOHNSON PTE
LTD
STRYKER SINGAPORE
PRIVATE LIMITED
MEDQUEST MARKETING
PTE LTD
BECTON DICKINSON
MEDICAL (S) PTE LTD
STRYKER NAVIGATION
SYSTEM, KNEE MODULE
ICU LOPEZ VALVE? ENTERAL
VALVE SYSTEM
BD PEGASUS? SAFETY
CLOSED IV CATHETER
SYSTEM
STRYKER SINGAPORE
STYKER NAVIGATION SYSTEM,
PRIVATE LIMITED
SPINE MODULE
BOSTON SCIENTIFIC ASIA
BOSTON SCIENTIFIC HYDRA
PACIFIC PTE. LTD.
JAGWIRE? GUIDEWIRE
SYNTHES SINGAPORE PTE. SYNTHES? INSTRUMENT SETS
LTD.
Page 14
HSAMDB01009
90181900
REFER TO CRPNS
90189090
HSAMDB01010
90183910
HSAMDB01010
90181900
REFER TO CRPNS
90189090
HSAMDB01010
90189030
REFER TO CRPNS
REMOVED IN
VERSION 2
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 11
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
HS CODE
HSA Product Code
Remarks
TLCNB00233
MD11542001F
38220090
HSAMDB01006
REMOVED IN
VERSION 10
TLCNB00234
MD11542017V
OCULUS PRIVATE LIMITED
HSAMDB01008
REMOVED IN
VERSION 11
TLCNB00235
MD11542026E
B. BRAUN SINGAPORE PTE
LTD
OCULUS FRESHKON?
90013000
EVERYDAYUV SOFT CONTACT
LENS
B. BRAUN SANGOFIX? BLOOD 90189020
ADMINISTRATION SET
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00237
MD11542037P
90183910
HSAMDB01010
MD11542061N
BECTON DICKINSON AND
COMPANY
BECTON DICKINSON AND
COMPANY
BD INSYTE? I.V. CATHETERS
TLCNB00238
BD I.V. START PAK? VASCULAR 90189020
ACCESS START KIT
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 11
TLCNB00239
MD11542184G
JMS SINGAPORE PTE LTD
JMS A.V. FISTULA NEEDLE SET 90183990
HSAMDB01010
TLCNB00240
MD11542188K
BD INSULIN SYRINGE
90183110
HSAMDB01010
TLCNB00241
MD11542203Z
BECTON DICKINSON AND
COMPANY
JMS SINGAPORE PTE LTD
90183990
HSAMDB01010
TLCNB00242
MD11542206C
JMS SINGAPORE PTE LTD
90189030
REFER TO CRPNS
TLCNB00243
MD11542224U
90189090
HSAMDB01009
TLCNB00244
MD11542238I
B. BRAUN SINGAPORE PTE
LTD
ZOHRA WAHAB TRADING
COMPANY PTE LTD
JMS SYSLOC? SAFETY A.V.
FISTULA/APHERESIS NEEDLE
SET
JMS HEMODIALYSIS BLOOD
TUBING SET
B. BRAUN DISCOFIX? C
90181900
REFER TO CRPNS
TLCNB00245
MD11542281Z
90183990
HSAMDB01010
TLCNB00246
MD11542287F
30051090
HSAMDB01010
TLCNB00247
MD11542385Z
90181900
REFER TO CRPNS
TLCNB00251
MD11542413B
90183200
HSAMDB01010
TLCNB00252
MD11542415D
90192000
REFER TO CRPNS
TLCNB00253
MD11542430S
38220090
HSAMDB01006
38220090
HSAMDB01006
REMOVED IN
VERSION 9
38220090
HSAMDB01006
REMOVED IN
VERSION 9
38220090
HSAMDB01006
REMOVED IN
VERSION 9
BECTON DICKINSON
MEDICAL (S) PTE LTD
3M TECHNOLOGIES (S) PTE. 3M UNITEK TRANSBOND? XT
LTD.
LIGHT CURE ADHESIVE
SYSTEM
LOZON (S) PTE. LTD.
A&D UA-767 PLUS UPPER ARM
DIGITAL BLOOD PRESSURE
MONITOR
LOZON (S) PTE. LTD.
A&D PALM TOP DIGITAL
BLOOD PRESSURE MONITOR
90183990
HSAMDB01010
33069000
HSAMDB01003
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90189030
REFER TO CRPNS
REMOVED IN
VERSION 10
90189030
REFER TO CRPNS
REMOVED IN
VERSION 10
BAXTER HEALTHCARE
(ASIA) PTE LTD
OCULUS PRIVATE LIMITED
BAXTER LIGHT SENSITIVE
DRUGS SET
OCULUS FRESHKON? 38 SOFT
CONTACT LENS
OCULUS FRESHKON? 58 UV
SOFT CONTACT LENS
OCULUS FRESHKON? COLORS
FUSION SOFT CONTACT LENS
90189020
HSAMDB01010
90013000
HSAMDB01008
90013000
HSAMDB01008
90013000
HSAMDB01008
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
OCULUS FRESHKON? NHANCE TORIC CONTACT
LENSES
OCULUS FRESHKON? A55
SOFT CONTACT LENS
OCULUS FRESHKON MOSAIC
CONTACT LENS
OCULUS FRESHKON? 55 SOFT
CONTACT LENS
OCULUS FRESHKON?
ALLURING EYES SOFT
CONTACT LENS
GORE TUNNELER
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
90013000
HSAMDB01008
90013000
HSAMDB01008
90013000
HSAMDB01008
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90189090
HSAMDB01009
TLCNB00253
TLCNB00253
Device name submitted under
"Device Info" section in
MEDICS
MCPHERSON'S CONSUMER SPD CLEARBLUE OVULATION
PRODUCTS PTE LTD
TEST
NIHON NISSEI WRIST TYPE
DIGITAL BLOOD PRESSURE
MONITOR
BECTON DICKINSON AND
BD MICRO-FINE? + PEN
COMPANY
NEEDLE
3M TECHNOLOGIES (S) PTE. 3M TEGADERM?+ PAD
LTD.
TRANSPARENT DRESSING
WITH ABSORBENT PAD
STRYKER SINGAPORE
STRYKER NAVIGATION
PRIVATE LIMITED
SYSTEM, ENT MODULE
COOK SOUTH EAST ASIA
COOK OVA-STIFF OVUM
PTE LTD
ASPIRATION NEEDLE (SINGLE
LUMEN)
COVIDIEN PRIVATE LIMITED COVIDIEN MALLINCKRODT
ULTRASONIC NEBULIZER
ABBOTT LABORATORIES
SENTINEL DIAGNOSTICS
(SINGAPORE ) PRIVATE
LITHIUM ASSAY (LN 8L25 AND
LIMITED
6K30)
SENTINEL DIAGNOSTICS UIBC
LIQUID ASSAY (LN 6K95 AND
6K30)
ABBOTT CLINICAL CHEMISTRY
CREATININE (ENZYMATIC)
ASSAY (LN 8L24 AND 6K30)
TLCNB00253
TLCNB00254
MD11542452O
TLCNB00255
MD11542472I
TLCNB00256
MD11542503N
TLCNB00257
MD11542507R
TLCNB00258
MD11542576I
TLCNB00259
MD11542610Q
SENTINEL DIAGNOSTICS
AMMONIA ULTRA ASSAY (LN
6K89)
BD HYPOINT? NEEDLES
TLCNB00259
TLCNB00259
TLCNB00259
TLCNB00259
TLCNB00259
TLCNB00259
TLCNB00259
TLCNB00260
MD11542786K
W.L. GORE & ASSOCIATES
(PACIFIC) PTE LTD
Page 15
REMOVED IN
VERSION 11
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 11
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
TLCNB00261
MD11542800Y
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00262
MD11542810I
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00263
MD11542828A
JMS SINGAPORE PTE LTD
TLCNB00264
MD11542835H
TLCNB00265
MD11542837J
Device name submitted under
"Device Info" section in
MEDICS
BAXTER CAPD DISPOSABLE
EFFLUENT SAMPLE BAG
HS CODE
HSA Product Code
Remarks
90189090
HSAMDB01010
REMOVED IN
VERSION 9
BAXTER CAPD DISPOSABLE
90183990
DISCONNECT Y-SET FOR USE
WITH UV-FLASH? GERMICIDAL
EXCHANGE DEVICE
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 10
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
JMS SCALP VEIN INFUSION
SET
BECTON DICKINSON
BD ECLIPSE? HYPODERMIC
MEDICAL (S) PTE LTD
NEEDLES
ARGON CRITICAL CARE
ARGON CRITIFLO? DOME
SYSTEMS SINGAPORE PTE.
LTD.
ARGON DOME BLOOD
SAMPLING SET
ARGON RT2000 TRIPLE DOME
SET
ARGON RT2000 SINGLE DOME
SET
ARGON RT2000 DUAL DOME
SET
ARGON RT2000 DOME BLOOD
SAMPLING SET
ARGON RT2000 DOME SET
90189020
HSAMDB01010
90183990
HSAMDB01010
90181900
REFER TO CRPNS
90181900
REFER TO CRPNS
90181900
REFER TO CRPNS
90181900
REFER TO CRPNS
90181900
REFER TO CRPNS
90181900
REFER TO CRPNS
90181900
REFER TO CRPNS
90181900
REFER TO CRPNS
90181900
REFER TO CRPNS
90181900
REFER TO CRPNS
TLCNB00265
ARGON GABARITH? TRIPLE
DOME SET
ARGON GABARITH? SINGLE
DOME SET
ARGON CRITIFLO? DOME SET
(GABARITH?-TESTED)
ARGON P10EZ? DOME SET
90181900
REFER TO CRPNS
TLCNB00265
ARGON TRIPLE DOME SET
90181900
REFER TO CRPNS
TLCNB00265
ARGON P23XL? DOME SET
90181900
REFER TO CRPNS
TLCNB00265
ARGON CRITIFLO? DOME SET
90181900
REFER TO CRPNS
TLCNB00265
ARGON DUAL DOME SET
90181900
REFER TO CRPNS
TLCNB00265
ARGON DOME / MANIFOLD SET 90181900
REFER TO CRPNS
BAXTER HOMECHOICE
PAEDIATIC/LOW
RECIRCULATION VOLUME
AUTOMATED PD SET WITH
CASSETTE R5C8303, FOR
LUER CONNECTION
PROCEDURE
BAXTER HOMECHOICE
AUTOMATED PD SET, WITH
CASSETTE
BAXTER EFFLUENT SAMPLE
BAG
BAXTER CYCLER DRAINAGE
BAG
B. BRAUN DIACAN? FISTULA
NEEDLES
BEIJING CHOICE FINGERTIP
PULSE OXIMETER
BD ECLIPSE? INJECTION
NEEDLE WITH LUER-LOK?
SYRINGE
ARGON ADMINISTRATION SET
90189090
HSAMDB01010
90189090
HSAMDB01010
REMOVED IN
VERSION 11
90189090
HSAMDB01010
90189090
HSAMDB01010
90183990
HSAMDB01010
90181900
REFER TO CRPNS
90183110
HSAMDB01010
REMOVED IN
VERSION 11
REMOVED IN
VERSION 11
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90183990
HSAMDB01010
REMOVED IN
VERSION 9
90183990
HSAMDB01010
90183990
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
TLCNB00270
ARGON SPC ACCESSORY
PRESSURE TUBING
ARGON HIGH PRESSURE
CONTRAST MEDIA INJECTION
TUBING
ARGON PRESSURE TUBING
90183990
HSAMDB01010
TLCNB00270
ARGON MANIFOLD SET
90183990
HSAMDB01010
TLCNB00270
ARGON FLOSWITCH?
90183990
HSAMDB01010
90189090
HSAMDB01010
90183990
HSAMDB01010
90183990
HSAMDB01010
TLCNB00265
TLCNB00265
TLCNB00265
TLCNB00265
TLCNB00265
TLCNB00265
TLCNB00265
TLCNB00265
TLCNB00265
TLCNB00266
MD11542881B
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00266
TLCNB00266
TLCNB00266
TLCNB00267
MD11542886G
TLCNB00268
MD11542904Y
TLCNB00269
MD11542937F
BECTON DICKINSON
MEDICAL (S) PTE LTD
TLCNB00270
MD11542949R
ARGON CRITICAL CARE
SYSTEMS SINGAPORE PTE.
LTD.
TLCNB00270
TLCNB00270
TLCNB00270
TLCNB00271
MD11542958A
TLCNB00272
MD11542964G
B. BRAUN SINGAPORE PTE
LTD
GREENSTYLE PTE LTD
ARGON CO ICE CONTAINER
BRACKET
ARGON CRITICAL CARE
ARGON MONITORING
SYSTEMS SINGAPORE PTE. EXTENSION SET
LTD.
ARGON CRITICAL CARE
ARGON SAFEDRAW? CLOSED
SYSTEMS SINGAPORE PTE. LOOP BLOOD SAMPLING SET
LTD.
Page 16
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VERSION 9
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VERSION 9
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VERSION 9
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VERSION 9
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VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 11
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
TLCNB00273
MD11542978U
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00274
MD11542984A
MEDQUEST MARKETING
PTE LTD
TLCNB00274
TLCNB00276
MD11543161V
TLCNB00278
MD11543245B
TLCNB00279
MD11543249F
TLCNB00280
MD11543251H
TLCNB00281
MD11543276G
TLCNB00282
MD11543289T
TLCNB00283
MD11543339R
TLCNB00284
MD11543348A
TLCNB00286
MD09517712A
TLCNB00286
TLCNB00287
MD09517954I
TLCNB00288
MD10519477X
TLCNB00289
MD10520347J
TLCNB00290
MD10520465X
TLCNB00291
MD10520474G
TLCNB00292
MD10520561P
TLCNB00293
MD10520642S
TLCNB00294
MD10520644U
TLCNB00295
MD10520645V
TLCNB00296
MD10520671V
TLCNB00297
MD10520691P
TLCNB00298
MD10520695T
TLCNB00299
MD10520703B
TLCNB00300
MD10520707F
TLCNB00301
MD10520721T
TLCNB00302
MD10520730C
TLCNB00304
MD10520777X
TLCNB00305
MD10520786G
Device name submitted under
"Device Info" section in
MEDICS
BAXTER CLEARLINK IV
ACCESS SYSTEM SOLUTION
SETS AND EXTENSION SETS
HS CODE
HSA Product Code
Remarks
90189020
HSAMDB01010
REMOVED IN
VERSION 11
ICU CLAVE? CONNECTOR
90183990
HSAMDB01010
ICU MICROCLAVE?
NEEDLEFREE IV SYSTEM
CONNECTOR
COVIDIEN PRIVATE LIMITED COVIDIEN DAR? CPAP /
BILEVEL CPAP TUBING
BECTON DICKINSON AND
BD VENFLON PRO? SAFETY
COMPANY
I.V. CATHETER/CANNULA
BECTON DICKINSON AND
BD NEOFLON? I.V. CATHETER
COMPANY
BECTON DICKINSON AND
BD VENFLON PRO? I.V.
COMPANY
CATHETER
ASIA MEDICAL SUPPLIES
YPSOMED PENFINE?
PTE LTD
UNIVERSAL CLICK PEN
NEEDLE
STRYKER SINGAPORE
STRYKER UNIVERSAL CMF
PRIVATE LIMITED
SYSTEM (INSTRUMENTS)
BECTON DICKINSON
BD PRECISIONGLIDE?
MEDICAL (S) PTE LTD
NEEDLES
BECTON DICKINSON
BD? SYRINGE WITH
MEDICAL (S) PTE LTD
PRECISIONGLIDE? NEEDLE
ST. JUDE MEDICAL
ENSITE VELOCITY SYSTEM
(SINGAPORE), PTE. LTD.
(EE3000)
ENSITE NAVX SURFACE
ELECTRODE KIT (EN0010)
STRYKER SINGAPORE
ADDITIONAL STRYKER HIP
PRIVATE LIMITED
INSTRUMENTS
BOSTON SCIENTIFIC ASIA
PCB
PACIFIC PTE. LTD.
JOHNSON & JOHNSON
1•DAY ACUVUE® DEFINE™
VISION CARE
AND 1•DAY ACUVUE®
DEFINE™ WITH LACREON™
OLYMPUS SINGAPORE PTE ENTEROSCOPY SYSTEM
LTD
GAMBRO SINGAPORE PTE. GAMBRO PRISMATHERM II
LTD.
BLOOD WARMER/EXTENSION
LINE
IDS MEDICAL SYSTEMS
SMITHS MEDICAL PORTEX
SILICONE LARYNGEAL MASK
90183990
HSAMDB01010
REMOVED IN
VERSION 6
REMOVED IN
VERSION 6
90192000
REFER TO CRPNS
90183910
HSAMDB01010
90183910
HSAMDB01010
90183910
HSAMDB01010
90183990
HSAMDB01010
90219000
HSAMDB01007
90183990
HSAMDB01010
90183110
HSAMDB01010
90181900
REFER TO CRPNS
90181900
REFER TO CRPNS
90189090
HSAMDB01009
90219000
HSAMDB01010
90013000
HSAMDB01008
90189090
HSAMDB01009
90189030
REFER TO CRPNS
90200000
HSAMDB01002
REMOVED IN
VERSION 9
OLYMPUS SINGAPORE PTE
LTD
OLYMPUS SINGAPORE PTE
LTD
OLYMPUS SINGAPORE PTE
LTD
OLYMPUS SINGAPORE PTE
LTD
OLYMPUS SINGAPORE PTE
LTD
OLYMPUS SINGAPORE PTE
LTD
OLYMPUS SINGAPORE PTE
LTD
DISPOSABLE CYTOLOGY
BRUSHES
ASPIRATION NEEDLES
90189090
HSAMDB01009
90183200
HSAMDB01010
INJECTORS
90189030
REFER TO CRPNS
EVIS EXERA SYSTEM
90181900
REFER TO CRPNS
OTV-SC FAMILY OF SYSTEMS
90181900
REFER TO CRPNS
CLIPS
90181900
REFER TO CRPNS
DISPOSABLE ENDOSCOPIC
90181900
MUCOSAL RESECTION (EMR)
KIT
OLYMPUS SINGAPORE PTE SINGLE USE ROTATABLE CLIP 90189090
LTD
FIXING DEVICE (QUICKCLIP)
REFER TO CRPNS
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
HSAMDB01010
REMOVED IN
VERSION 9
OLYMPUS SINGAPORE PTE
LTD
OLYMPUS SINGAPORE PTE
LTD
SORIN GROUP ASIA PTE.
LTD.
PROHEALTH PTE LTD
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
VISERA SYSTEM
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90181900
REFER TO CRPNS
EVIS EXERA
90181900
PLEURAVIDEOSCOPE
LILLIPUT ECMO OXYGENATOR 90200000
REFER TO CRPNS
TECO URINE REAGENT STRIPS 38220090
FOR URINALYSIS (URS-1P)
HSAMDB01006
TLCNB00305
TECO URINE REAGENT STRIPS 38220090
FOR URINALYSIS (URS-2K)
HSAMDB01006
REMOVED IN
VERSION 9
TLCNB00305
TECO URINE REAGENT STRIPS 38220090
FOR URINALYSIS (URS-4B)
HSAMDB01006
REMOVED IN
VERSION 9
TLCNB00305
TECO URINE REAGENT STRIPS 38220090
FOR URINALYSIS (URS-4S)
HSAMDB01006
REMOVED IN
VERSION 9
TLCNB00305
TECO URINE REAGENT STRIPS 38220090
FOR URINALYSIS (URS-6)
HSAMDB01006
REMOVED IN
VERSION 9
TLCNB00305
TECO URINE REAGENT STRIPS 38220090
FOR URINALYSIS (URS-10)
HSAMDB01006
REMOVED IN
VERSION 9
TLCNB00305
TECO URINE REAGENT STRIPS 38220090
FOR URINALYSIS (URS-1K)
HSAMDB01006
REMOVED IN
VERSION 9
Page 17
HSAMDB01002
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
HSA Product Code
Remarks
HSAMDB01006
REMOVED IN
VERSION 9
HSAMDB01009
REMOVED IN
VERSION 9
SMITHS MEDICAL PORTEX 1ST 90189030
RESPONSE MANUAL
RESUSCITATOR
CORDIS VESSEL DILATORS
90189090
REFER TO CRPNS
REMOVED IN
VERSION 9
HSAMDB01009
TLCNB00308
CORDIS AVANTI® + CATHETER 90189090
SHEATH INTRODUCER
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
TLCNB00308
HSAMDB01010
JOHNSON & JOHNSON
MEDICAL SINGAPORE
JOHNSON & JOHNSON
MEDICAL SINGAPORE
CORDIS AVANTI® +
90189090
TRANSRADIAL KIT
CORDIS MICRO GUIDE
90183910
CATHETER XP
ASP EVOTECH™ ENDOSCOPE 84192000
CLEANER AND REPROCESSOR
TLCNB00305
Device name submitted under HS CODE
"Device Info" section in
MEDICS
TECO URINE REAGENT STRIPS 38220090
FOR URINALYSIS (URS-6L)
TLCNB00306
MD10520787H
3M TECHNOLOGIES (S) PTE. 3M™ LITTMANN™
LTD.
ELECTRONIC STETHOSCOPE.
TLCNB00307
MD10520906W
IDS MEDICAL SYSTEMS
TLCNB00308
MD10521086U
JOHNSON & JOHNSON
MEDICAL SINGAPORE
90189090
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
TLCNB00309
MD10521087V
TLCNB00310
MD10521123F
TLCNB00311
MD10521125H
BOSTON SCIENTIFIC ASIA
PACIFIC PTE. LTD.
RIGIFLEX™ II SINGLE USE
90189090
ACHALASIA BALLOON DILATOR
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00312
MD10521135R
SORIN GROUP ASIA PTE.
LTD.
90189090
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00313
MD10521147D
39269039
HSAMDB01010
TLCNB00315
MD10521220Y
38089490
HSAMDB01005
TLCNB00316
MD10521221Z
38089490
HSAMDB01005
TLCNB00318
MD10522150S
SORIN GROUP ASIA PTE.
LTD.
JOHNSON & JOHNSON
MEDICAL SINGAPORE
JOHNSON & JOHNSON
MEDICAL SINGAPORE
IGEL FAR EAST PTE LTD
ELECTA AUTOTRANSFUSION
CELL SEPARATOR
DISPOSABLES
SORIN DATA MASTER
DISPOSABLES
ASP CIDEX® OPA
CONCENTRATE SOLUTION
CIDEX® OPA SOLUTION
90013000
HSAMDB01008
TLCNB00320
MD10522491V
90189090
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90189090
HSAMDB01009
90183990
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90189090
HSAMDB01009
90183910
HSAMDB01010
HSAMDB01005
TLCNB00321
MD10522546Y
ALCON PTE LTD
TLCNB00322
MD10522864E
IDS MEDICAL SYSTEMS
TLCNB00323
MD10523393N
ALCON PTE LTD
TLCNB00324
MD10523513D
B. BRAUN SINGAPORE PTE
LTD
TLCNB00325
MD10523672G
CADI SCIENTIFIC PTE. LTD.
IGEL ENCORE COLOURS
REPLACEMENT
ANGIODYN® HIGH PRESSURE
MANIFOLD, THREE-PORT OFF
VERSION
ANGIODYN® HIGH PRESSURE
MANIFOLD, TWO-PORT OFF
VERSION
ANGIODYN® HIGH PRESSURE
MANIFOLD, TWO-PORT ON
VERSION
ANGIODYN® MID PRESSURE
MANIFOLD, THREE-PORT OFF
VERSION
ANGIODYN® MID PRESSURE
MANIFOLD, THREE-PORT ON
VERSION
ANGIODYN® MID PRESSURE
MANIFOLD, TWO-PORT OFF
VERSION
ALCON® GRIESHABER® SOFT
TIP CANNULA
FEMCARE-NIKOMED
DISPOSABLE SEALS [FE-20S915]
ALCON A-OK® OPHTHALMIC
KNIFE
COMBIDYN® PRESSURE
MONITORING TUBINGS AND
ADAPTORS
NOT APPLICABLE
90251919
HSAMDB01004
TLCNB00326
MD10523999V
MD10524054Y
TLCNB00328
MD10524335T
STERRAD® 200 STERILIZATION 84192000
SYSTEM
GAMBRO AV-FISTULA NEEDLE 90183990
(MODEL : F17BFS)
ASP AUTOMATED ENDOSCOPE 84192000
REPROCESSOR (AER)
HSAMDB01005
TLCNB00327
JOHNSON & JOHNSON
MEDICAL SINGAPORE
GAMBRO SINGAPORE PTE.
LTD.
JOHNSON & JOHNSON
MEDICAL SINGAPORE
TLCNB00329
MD10524405L
B. BRAUN SINGAPORE PTE
LTD
90189090
HSAMDB01009
REMOVED IN
VERSION 9
TLCNB00329
CONTIPLEX D CONTINUOUS
NERVE BLOCK SETS,
CONTIPLEX CATHETER AND
CANNULAE
CONTIPLEX S SETS
90189090
HSAMDB01009
TLCNB00329
CONTIPLEX TUOHY SETS
90189090
HSAMDB01009
TERUFUSION® SOLUTION
ADMINISTRATION SET E FOR
INFUSION PUMP
NIM NEURO 2.0
90183910
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90189090
HSAMDB01009
ECG-1150/NIHON KOHDEN
CARDIOFAX C
ELECTROCARDIOGRAPH
90181100
HSAMDB01004
B. BRAUN SINGAPORE PTE
LTD
TLCNB00320
TLCNB00320
TLCNB00320
TLCNB00320
TLCNB00320
TLCNB00330
MD10524425F
TERUMO CORPORATION
SINGAPORE BRANCH
TLCNB00332
MD10524528E
TLCNB00333
MD10524535L
MEDTRONIC
INTERNATIONAL, LTD.
NIHON KOHDEN
SINGAPORE PTE LTD
Page 18
HSAMDB01010
HSAMDB01005
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
TLCNB00333
TLCNB00333
TLCNB00334
MD10524544U
NIHON KOHDEN
SINGAPORE PTE LTD
TLCNB00335
MD10524564O
TLCNB00337
MD10524636I
B. BRAUN SINGAPORE PTE
LTD
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00338
MD10524640M
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00339
MD10524642O
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00339
TLCNB00339
TLCNB00339
TLCNB00340
MD10524645R
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00340
TLCNB00341
MD10524646S
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00341
TLCNB00344
MD10524649V
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00345
MD10524650W
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00345
TLCNB00345
TLCNB00345
TLCNB00345
TLCNB00346
MD10524651X
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00346
TLCNB00347
TLCNB00347
MD10524652Y
BAXTER HEALTHCARE
(ASIA) PTE LTD
Device name submitted under
"Device Info" section in
MEDICS
ECG-1250K/NIHON KOHDEN
CARDIOFAX S
ELECTROCARDIOGRAPH
ECG-1350K/NIHON KOHDEN
CARDIOFAX M
ELECTROCARDIOGRAPH
MEB-2200K/NIHON KOHDEN
NEUROPACK X1 EP/EMG
MEASURING SYSTEM
STIMUPLEX® D NEEDLES
HS CODE
HSA Product Code
Remarks
90181100
HSAMDB01004
REMOVED IN
VERSION 9
90181100
HSAMDB01004
REMOVED IN
VERSION 9
90181100
HSAMDB01004
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90183200
HSAMDB01010
BAXTER INTERLINK T90183910
CONNECTOR EXTENSION SET
(PRODUCT CODE 2N3328)
HSAMDB01010
BAXTER SPIKE WITH
CLEARLINK (PRODUCT CODE
EMC1402)
ALL-IN-ONE EMPTY EVA
CONTAINERS FOR GRAVITY
TRANSFER WITH THREE LEAD
TRANSFER SET (PRODUCT
CODES 2B8114)
ALL-IN-ONE EMPTY EVA
CONTAINERS FOR GRAVITY
TRANSFER WITH THREE LEAD
TRANSFER SET (PRODUCT
CODES 2B8124)
ALL-IN-ONE EMPTY EVA
CONTAINERS FOR GRAVITY
TRANSFER WITH THREE LEAD
TRANSFER SET (PRODUCT
CODES 2B8134)
ALL-IN-ONE EMPTY EVA
CONTAINERS FOR GRAVITY
TRANSFER WITH THREE LEAD
TRANSFER SET (PRODUCT
CODES 2B8144)
BAXTER CATHETER
EXTENSION SET (PRODUCT
CODE EMC9190)
BAXTER CATHETER
EXTENSION SET (PRODUCT
CODE EMC9191)
BAXTER ALL-IN-ONE EMPTY
EVA CONTAINER (PRODUCT
CODE 2B8152)
BAXTER AUTOMIX 3+3
COMPOUNDER 6 LEAD
TRANSFER SET (PRODUCT
CODE 2C0477)
BAXTER AP II PUMP SETS
(PRODUCT CODES 2L3512,
2L3513, 2L3520, 2L3522,
2L3523)
BAXTER SOLUTION
ADMINISTRATION SET WITH
CLEARLINK VALVE (PRODUCT
CODE EMC9680)
BAXTER SOLUTION
ADMINISTRATION SET
(PRODUCT CODE EMC5883P)
90189020
HSAMDB01010
REMOVED IN
VERSION 9
90183910
HSAMDB01010
REMOVED IN
VERSION 9
90183910
HSAMDB01010
REMOVED IN
VERSION 9
90183910
HSAMDB01010
REMOVED IN
VERSION 9
90183910
HSAMDB01010
REMOVED IN
VERSION 9
90183910
HSAMDB01010
REMOVED IN
VERSION 9
90183910
HSAMDB01010
REMOVED IN
VERSION 9
90183910
HSAMDB01010
REMOVED IN
VERSION 9
90183910
HSAMDB01010
REMOVED IN
VERSION 9
90189020
HSAMDB01010
REMOVED IN
VERSION 9
90189020
HSAMDB01010
REMOVED IN
VERSION 9
90189020
HSAMDB01010
REMOVED IN
VERSION 9
BAXTER SOLUTION
ADMINISTRATION SET
(PRODUCT CODE EMC9618)
BAXTER SOLUTION
ADMINISTRATION SET
(PRODUCT CODE RMC5869)
BAXTER SOLUTION
ADMINISTRATION SET WITH
CLEARLINK (PRODUCT CODE
EMC9667)
BAXTER SOLUTION
ADMINISTRATION PUMP SET
(PRODUCT CODES FMC9650
AND FMC9604)
SOLUTION ADMINISTRATION
SET (PRODUCT CODE
RMC9604)
BAXTER Y-TYPE EXTENSION
SET (PRODUCT CODES
EMC3371, EMC3335, EMC9192,
RMC0055M)
Y TYPE EXTENSION SET,
NARROW BORE, 3 CLEARLINK
VALVES (PRODUCT CODE
EMC5927)
90189020
HSAMDB01010
REMOVED IN
VERSION 9
90189020
HSAMDB01010
REMOVED IN
VERSION 9
90189020
HSAMDB01010
REMOVED IN
VERSION 9
90189020
HSAMDB01010
REMOVED IN
VERSION 9
90189020
HSAMDB01010
REMOVED IN
VERSION 9
90189020
HSAMDB01010
REMOVED IN
VERSION 9
90183990
HSAMDB01010
REMOVED IN
VERSION 9
Page 19
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
TLCNB00348
MD10524710E
B. BRAUN SINGAPORE PTE
LTD
TLCNB00348
TLCNB00349
MD10524729X
TLCNB00350
MD10524738G
JOHNSON & JOHNSON
MEDICAL SINGAPORE
JOHNSON & JOHNSON
MEDICAL SINGAPORE
TLCNB00350
TLCNB00350
TLCNB00350
TLCNB00351
MD10524793J
TLCNB00352
MD10524830U
TLCNB00353
MD10524837B
TLCNB00354
MD10524847L
TLCNB00355
MD10524922I
TLCNB00355
TLCNB00355
TLCNB00356
MD10524926M
TLCNB00357
MD10524929P
TLCNB00358
MD10524939Z
TLCNB00359
MD10524946G
TLCNB00360
MD10524949J
TLCNB00361
MD10524953N
TLCNB00362
MD10524959T
TLCNB00363
MD10524998G
TLCNB00364
MD10525024G
B. BRAUN SINGAPORE PTE
LTD
BAXTER HEALTHCARE
(ASIA) PTE LTD
B. BRAUN SINGAPORE PTE
LTD
BAXTER HEALTHCARE
(ASIA) PTE LTD
BAXTER HEALTHCARE
(ASIA) PTE LTD
REMOVED IN
VERSION 9
STIMUPLEX® HNS 12
90180930
REFER TO CRPNS
DEPUY MITEK CLEAR
CANNULA SYSTEM
ETHICON ENDO-SURGERY
PROXIMATE® RH TOTATING
HEAD SKIN STAPLER
ETHICON ENDO-SURGERY
PROXIMATE® SKIN STAPLE
EXTRACTOR
ETHICON ENDO-SURGERY
PROXIMATE® SKIN STAPLER
90189090
HSAMDB01010
90189090
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90189090
HSAMDB01010
REMOVED IN
VERSION 9
ETHICON ENDO-SURGERY
PROXIMATE® PLUS MD MULTIDIRECTIONAL RELEASE SKIN
STAPLER
ORIGINAL PERFUSOR®
TUBINGS
3-WAY STOPCOCK (PRODUCT
CODE ZMC7401)
OMNIFIX® SYRINGE
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90183910
HSAMDB01010
90183910
HSAMDB01010
90183910
HSAMDB01010
CONTROL-A-FLO SET
90183990
(PRODUCT CODE FMC9505)
CYSTO/BLADDER IRRIGATION 90183910
SET (PRODUCT CODE 2C4040)
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
HSAMDB01010
90183910
HSAMDB01010
90181900
REFER TO CRPNS
90183910
HSAMDB01010
90181900
REFER TO CRPNS
90189090
HSAMDB01010
90189090
HSAMDB01009
90185000
HSAMDB01008
90183990
HSAMDB01010
RESTORE™ ACL
RECONSTRUCTION SYSTEM
BIOSENSE WEBSTER
COOLFLOW® IRRIGATION
PUMP
BIOSENSE WEBSTER
COOLFLOW® IRRIGATION
TUBING SET
BIOSENSE WEBSTER
ESOPHASTAR® ESOPHAGEAL
MAPPING CATHETER
90189090
HSAMDB01010
90189030
REFER TO CRPNS
90189020
HSAMDB01010
REMOVED IN
VERSION 9
90189020
HSAMDB01010
REMOVED IN
VERSION 9
MINICAP WITH POVIDONEIODINE (PRODUCT CODE
SPC4466)
PD CATHETER CLAMP
(PRODUCT CODE RPC4171)
CONNECTION SHIELD SYSIIK
WITH POVIDONE-IODINE
SOLUTION (PRODUCT CODE
SPC4213)
LOCKING TITANIUM ADAPTER
FOR PERITONEAL DIALYSIS
CATHETER (PRODUCT CODE
5C4129)
BIOSENSE WEBSTER NOGA®
REFSTAR™ EXTERNAL
REFERENCE PATCH
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90189090
HSAMDB01010
90189090
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
BIOSENSE WEBSTER
REFSTAR™ PLUS CABLE
BIOSENSE WEBSTER
REFSTAR™ PLUS WITH
QWIKPATCH® EXTERNAL
REFERENCE PATCH
90189030
REFER TO CRPNS
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
JOHNSON & JOHNSON
MEDICAL SINGAPORE
JOHNSON & JOHNSON
MEDICAL SINGAPORE
JOHNSON & JOHNSON
MEDICAL SINGAPORE
TLCNB00366
MD10525063T
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00366
TLCNB00366
TLCNB00366
TLCNB00368
HSAMDB01010
HSAMDB01010
MD10525037T
TLCNB00368
Remarks
90183910
TLCNB00365
MD10525163P
HSA Product Code
VIAL-MATE ADAPTOR
(PRODUCT CODE 2B8071)
Y-TYPE TUR/BLADDER
IRRIGATION SET (PRODUCT
CODE 2C4041)
OLYMPUS SINGAPORE PTE VISERA SYSTEM
LTD
BAXTER HEALTHCARE
BAXTER Y-TYPE
(ASIA) PTE LTD
BLOOD/SOLUTION SET
(PRODUCT CODE 2C7627)
OLYMPUS SINGAPORE PTE EVIS EXERA SYSTEM
LTD
BAXTER HEALTHCARE
TISSEEL/ARTISS SPRAY SET
(ASIA) PTE LTD
(PRODUCT CODES 0600065
AND 0600066)
JOHNSON & JOHNSON
PATHSEEKER™ SUTURE
MEDICAL SINGAPORE
PASSER
OLYMPUS SINGAPORE PTE EVIS LUCERA SYSTEM
LTD
BAXTER HEALTHCARE
BAXTER CLEARLINK VENTED
(ASIA) PTE LTD
BLOOD ADMINISTRATION SET
(PRODUCT CODE FMC9682P)
TLCNB00364
TLCNB00368
Device name submitted under HS CODE
"Device Info" section in
MEDICS
STIMUPLEX® A NEEDLES WITH 90183200
30° SHORT-BEVEL-NEEDLE
JOHNSON & JOHNSON
MEDICAL SINGAPORE
Page 20
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
TLCNB00368
TLCNB00369
MD10525167T
JOHNSON & JOHNSON
MEDICAL SINGAPORE
TLCNB00370
MD10525177D
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00370
TLCNB00371
MD10525372Q
BAXTER HEALTHCARE
(ASIA) PTE LTD
TLCNB00372
MD10525548K
TLCNB00373
MD10525589Z
JOHNSON & JOHNSON
MEDICAL SINGAPORE
IDS MEDICAL SYSTEMS
TLCNB00374
MD10525619D
TLCNB00375
MD10525627L
TLCNB00378
MD10525672E
TLCNB00379
MD10525692Y
TLCNB00380
MD10525746A
TLCNB00381
MD10525840Q
TLCNB00382
MD10525857H
JOHNSON & JOHNSON
MEDICAL SINGAPORE
TLCNB00383
MD10525925X
TLCNB00384
MD10525986G
JOHNSON & JOHNSON
MEDICAL SINGAPORE
TRUMED INTERNATIONAL
PTE LTD
PROGRESS HEALTHCARE
PTE. LTD.
MORITA MEDICAL
ENGINEERING SINGAPORE
PTE. LTD.
GAMBRO SINGAPORE PTE.
LTD.
ORTHO-CLINICAL
DIAGNOSTICS
PHILIPS ELECTRONICS
SINGAPORE PTE LTD
JOHNSON & JOHNSON
MEDICAL SINGAPORE
MD10526034C
TLCNB00386
MD10526116G
TLCNB00387
MD10526394Y
TLCNB00388
MD10526455H
TLCNB00389
MD10526464Q
TLCNB00390
MD10526624U
TLCNB00390
TLCNB00391
MD10526628Y
TLCNB00392
MD10526632C
TLCNB00393
MD10526740G
TLCNB00393
TLCNB00394
MD10527200Y
TLCNB00395
MD10527202A
TLCNB00395
TLCNB00397
MD10527351T
Remarks
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
90189020
HSAMDB01010
REMOVED IN
VERSION 9
90189020
HSAMDB01010
90189090
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90183910
HSAMDB01010
90183910
HSAMDB01010
90189090
HSAMDB01010
90184900
REFER TO CRPNS
90183910
HSAMDB01010
REMOVED IN
VERSION 9
ORTHO BLISS
38220090
HSAMDB01006
DIGITRAK XT RECORDER
90181100
HSAMDB01004
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REFER TO CRPNS
REMOVED IN
VERSION 9
J-VAC™ CLOSED WOUND
DRAINAGE SYSTEM
EPIMED™ RX²™ COUDE®
EPIDURAL NEEDLE
EPIMED™ RK™ EPIDURAL
NEEDLE
BIO-RAD VIROTROL IV
90183910
HSAMDB01010
90183990
HSAMDB01010
90183990
HSAMDB01010
BIO-RAD LABORATORIES
(SINGAPORE) PTE LTD
AMO SINGAPORE PTE.
AMO TAC INFUSION SLEEVE
LIMITED
KIMBERLY-CLARK FAR EAST KIMBERLY-CLARK* ENTERAL
PTE. LIMITED
ACCESS DILATION SYSTEM
38220090
HSAMDB01006
90189090
HSAMDB01010
90189090
HSAMDB01009
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
AMO SINGAPORE PTE.
LIMITED
90189090
HSAMDB01009
REMOVED IN
VERSION 11
40151100
HSAMDB01010
REMOVED IN
VERSION 9
38220090
HSAMDB01006
38220090
HSAMDB01006
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
38089490
HSAMDB01005
38089490
HSAMDB01005
38220090
HSAMDB01006
38220090
HSAMDB01006
90189020
HSAMDB01010
REMOVED IN
VERSION 9
BIOMED DIAGNOSTICS PTE QUADRUPLE BAG TOP TOP
90189090
LTD
LQE
TRIPLE BAG TOP BOTTOM MRT 90189090
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
AMO LAMINAR® FLOW
INFUSION SLEEVE AND TEST
CHAMBER 20 GAUGE
IDS MEDICAL SYSTEMS
ANSELL GAMMEX® PF
SENSITIVE™ SURGICAL
GLOVES
DKSH SINGAPORE PTE.
SIEMENS ADVIA CENTAUR
LTD.
HAV IGM ASSAY
SIEMENS ADVIA CENTAUR
HAV IGM QUALITY CONTROL
MATERIAL
KIMBERLY-CLARK FAR EAST KIMBERLY-CLARK* SINGLE
PTE. LIMITED
DOSE SALINE VIALS
KIMBERLY-CLARK FAR EAST KIMBERLY-CLARK* SINGLE
PTE. LIMITED
DOSE SALINE VIALS
DKSH SINGAPORE PTE.
SIEMENS ADVIA CENTAUR
LTD.
HAV TOTAL ASSAY
SIEMENS ADVIA CENTAUR
HAV TOTAL QUALITY
CONTROL MATERIAL
B. BRAUN SINGAPORE PTE VENOFIX® A VENEPUNCTURE
LTD
SET WITH FIXATION WING
TLCNB00395
MD10527207F
HSA Product Code
REFER TO CRPNS
TLCNB00395
TLCNB00396
HS CODE
BIOSENSE WEBSTER CARTO® 90180930
XP SYSTEM WITH
CARTOXPRESS™ MODULE
(V10)
BIOSENSE WEBSTER CARTO® 90180930
RMT EP NAVIGATION SYSTEM
TLCNB00384
TLCNB00385
Device name submitted under
"Device Info" section in
MEDICS
BIOSENSE WEBSTER
REFSTAR™ WITH
QWIKPATCH® EXTERNAL
REFERENCE PATCH
BIOSENSE WEBSTER
REFSTAR™ RMT EXTERNAL
REFERENCE PATCH
BAXTER VENTED PACLITAXEL
SET (PRODUCT CODE
EMC9627)
VENTED PACLITAXEL SET
(PRODUCT CODE VMC9627)
EASYSPRAY PRESSURE
REGULATOR (PRODUCT CODE
0600075)
OUTBACK® LTD™ RE-ENTRY
CATHETER
SMITHS MEDICAL PORTEX
BLUNT TIP TROCAR
CATHETER
ROCKET® 3 POSITION LUER
STOPCOCK
MORITA TWINPOWER
TURBINE 4H(E)X DENTAL
HANDPIECES
MEDICAL LINES - GMB-AV 28,
GMB-AV 33, CBL-E 10-E4C
B. BRAUN SINGAPORE PTE
LTD
ZOHRA WAHAB TRADING
COMPANY PTE LTD
QUADRUPLE BAG TOP
BOTTOM LQT
QUADRUPLE BAG TOP
BOTTOM MQT
INTROCAN® SAFETY™ I.V.
CANNULA
NISSEI AUTO INFLATION
DIGITAL BLOOD PRESSURE
MONITOR - MODEL: DS-500
Page 21
HSAMDB01010
90189090
HSAMDB01010
90189090
HSAMDB01010
90189020
HSAMDB01010
90181900
REFER TO CRPNS
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
Device name submitted under HS CODE
"Device Info" section in
MEDICS
NISSEI AUTO INFLATION
90181900
DIGITAL BLOOD PRESSURE
MONITOR - MODEL: DS-700
NISSEI DIGITAL MERCURY
90181900
FREE SPHYGMOMANOMETER MODEL: DM-1000
HSA Product Code
Remarks
REFER TO CRPNS
REMOVED IN
VERSION 9
REFER TO CRPNS
REMOVED IN
VERSION 9
PLEXUFIX® SET WITH 45°
SHORT-BEVEL NEEDLE AND
EXTENSION TUBING
SMITHS MEDICAL PORTEX
PERCUTANEOUS DILATION KIT
WITH BLUE LINE ULTRA
SUCTIONAID TRACHEOSTOMY
TUBE
KENDALL RESPIFLO MN
ADAPTER*
JITRON DIGITAL ARM BLOOD
PRESSURE MONITOR BPI-901A
90183990
HSAMDB01010
REMOVED IN
VERSION 9
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90189090
HSAMDB01010
90180930
REFER TO CRPNS
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
SYNTHES SINGAPORE PTE. BATTERY POWER LINE
LTD.
IDS MEDICAL SYSTEMS
ANSELL GAMMEX® PF LATEX
SURGICAL GLOVES – POWDER
FREE
IDS MEDICAL SYSTEMS
SMITHS MEDICAL PORTEX
CATHETER MOUNT WITH
15/22MM FEMALE
TERMINATIONS - NON
CONDUCTIVE [100/590/000]
SMITHS MEDICAL PORTEX
CATHETER MOUNT WITH
ANGLED 15MM FEMALE
DOUBLE SWIVEL CONNECTOR
AND STRAIGHT 22MM FEMALE
CONNECTOR [100/594/000]
90180930
REFER TO CRPNS
40151100
HSAMDB01010
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90189090
HSAMDB01010
REMOVED IN
VERSION 9
SMITHS MEDICAL PORTEX
NON STERILE 15MM FEMALE
CATHETER MOUNT ADAPTOR
[100/251/001]
SMITHS MEDICAL PORTEX
RESUABLE SWIVEL
CONNECTOR 15MM
[100/250/001]
PORTEX 15MM DOUBLE
SWIVEL CONNECTOR
SMITHS MEDICAL PORTEX 15
MM FIBREOPTIC
BRONCHOSCOPE SWIVEL
CONNECTOR [100/257/000]
SMITHS MEDICAL PORTEX
15MM "Y" PIECE [100/276/000]
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90189090
HSAMDB01010
90189090
HSAMDB01009
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90189090
HSAMDB01010
REMOVED IN
VERSION 9
KIMBERLY-CLARK FAR EAST KIMBERLY-CLARK* KIMVENT*
PTE. LIMITED
CLOSED SUCTION SYSTEM
FOR NEONATES/PEDIATRICS
(ELBOW)
90189090
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00407
KIMBERLY-CLARK* KIMVENT*
CLOSED SUCTION SYSTEM
FOR NEONATES/PEDIATRICS
(Y ADAPTER)
90189090
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00407
KIMBERLY-CLARK* KIMVENT*
MULTI-ACCESS CATHETER
90183910
HSAMDB01010
REMOVED IN
VERSION 9
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90185000
HSAMDB01008
90185000
HSAMDB01008
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90185000
HSAMDB01008
90189090
HSAMDB01010
STRYKER STRYKEFLOW PS
90189090
SUCTION/IRRIGATION SYSTEM
HSAMDB01010
REMOVED IN
VERSION 9
TLCNB00397
TLCNB00397
TLCNB00398
MD10527416G
B. BRAUN SINGAPORE PTE
LTD
TLCNB00399
MD10527474M
IDS MEDICAL SYSTEMS
TLCNB00401
MD10527716U
TLCNB00402
MD10527777D
TYCO HEALTHCARE PTE
LTD
JITRON PTE. LTD.
TLCNB00403
MD10527903Z
TLCNB00404
MD10528131T
TLCNB00405
MD10528320A
TLCNB00405
TLCNB00405
TLCNB00405
TLCNB00405
TLCNB00405
TLCNB00405
TLCNB00407
MD10528394W
TLCNB00408
MD10528837X
TLCNB00409
MD10528967X
TLCNB00410
MD10528975F
TLCNB00410
TLCNB00411
MD11529702E
IDS MEDICAL SYSTEMS
PORTEX EPIDURAL FLAT
FILTER WITH LUER LOCK
FITTINGS
OLYMPUS SINGAPORE PTE OLYMPUS® EVIS EXERA II
LTD
ENDOSCOPY SYSTEM
OLYMPUS SINGAPORE PTE OLYMPUS® EVIS LUCERA
LTD
COLONOVIDEOSCOPE PCF-260
SERIES
OLYMPUS® EVIS LUCERA
COLONOVIDEOSCOPE
STRYKER SINGAPORE
STRYKER STRYKEFLOW 2
PRIVATE LIMITED
SUCTION/IRRIGATION SYSTEM
TLCNB00411
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
TLCNB00412
MD11529939H
STRYKER SINGAPORE
PRIVATE LIMITED
STRYKER REFLEX HYBRID
ANTERIOR CERVICAL PLATE
SYSTEM (INSTRUMENTS)
90189090
HSAMDB01009
REMOVED IN
VERSION 9
TLCNB00413
MD11530199H
SMITH & NEPHEW PTE
LIMITED
SMITH & NEPHEW
90189090
DISPOSABLE DRILL BITS (NONSTERILE)
HSAMDB01009
REMOVED IN
VERSION 9
Page 22
Class B Medical Device Transition List (Change Notification Applications)
Version 15 (Publication Date: 04 April 2014)
Transition List
No.
Job Reference No. Registrant
TLCNB00414
MD11530395V
SMITH & NEPHEW PTE
LIMITED
TLCNB00415
MD11530509F
BOSTON SCIENTIFIC ASIA
PACIFIC PTE. LTD.
TLCNB00416
MD11530778O
BOSTON SCIENTIFIC ASIA
PACIFIC PTE. LTD.
TLCNB00417
MD11530785V
BOSTON SCIENTIFIC ASIA
PACIFIC PTE. LTD.
TLCNB00418
MD11531067R
OCULUS PRIVATE LIMITED
TLCNB00418
TLCNB00418
TLCNB00418
TLCNB00419
MD11531072W
OCULUS PRIVATE LIMITED
TLCNB00420
MD11531577H
SMITH & NEPHEW PTE
LIMITED
TLCNB00421
MD11531606K
STRYKER SINGAPORE
PRIVATE LIMITED
TLCNB00422
MD11531733H
TLCNB00423
MD11531734I
STRYKER SINGAPORE
PRIVATE LIMITED
STRYKER SINGAPORE
PRIVATE LIMITED
TLCNB00424
MD11531737L
STRYKER SINGAPORE
PRIVATE LIMITED
TLCNB00425
MD11531786I
TLCNB00426
MD11531847R
THE LARYNGEAL MASK
COMPANY (SINGAPORE)
PTE. LTD.
SIEMENS HEALTHCARE
DIAGNOSTICS PTE. LTD.
TLCNB00426
TLCNB00427
MD11531863H
TLCNB00428
MD11531879X
TLCNB00429
MD11536648I
STRYKER SINGAPORE
PRIVATE LIMITED
RAINTREE MEDICAL PTE.
LTD.
ABBOTT LABORATORIES
(SINGAPORE ) PRIVATE
LIMITED
TLCNB00429
TLCNB00430
MD11537419Z
TLCNB00433
MD12550088G
STRYKER SINGAPORE
PRIVATE LIMITED
MEDQUEST MARKETING
PTE LTD
Device name submitted under
"Device Info" section in
MEDICS
SMITH & NEPHEW DIRECT
VIEW ARTHROSCOPE (NONAUTOCLAVABLE)
BOSTON SCIENTIFIC RADIAL
JAW™ 4 SINGLE-USE BIOPSY
FORCEPS
BOSTON SCIENTIFIC UROMAX
ULTRA™ HIGH PRESSURE
BALLOON DILATATION
CATHETERS WITH
HYDROPLUS™ COATING
HS CODE
HSA Product Code
Remarks
90189090
HSAMDB01009
REMOVED IN
VERSION 9
90189090
HSAMDB01009
REMOVED IN
VERSION 9
90189090
HSAMDB01010
REMOVED IN
VERSION 9
BOSTON SCIENTIFIC
NEPHROMAX™ HIGH
PRESSURE BALLOON
DILATATION CATHETER
OCULUS BOSTON XO2
(HEXAFOCON B) DAILY WEAR
GAS PERMEABLE CONTACT
LENS
OCULUS BOSTON EO
(ENFLUFOCON B) DAILY WEAR
GAS PERMEABLE CONTACT
LENS
OCULUS BOSTON ES
(ENFLUFOCON A) DAILY WEAR
GAS PERMEABLE CONTACT
LENS
OCULUS BOSTON XO
(HEXAFOCON A) DAILY WEAR
GAS PERMEABLE CONTACT
LENS
OCULUS ORTHOKERATOLOGY
CONTACT LENS
90189090
HSAMDB01010
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
90013000
HSAMDB01008
REMOVED IN
VERSION 9
SMITH & NEPHEW GENESIS® II
TOTAL KNEE SYSTEMPOSTERIOR STABILIZED HIGH
FLEXION ARTICULAR INSERT
TRIAL
STRYKER PCD
PERCUTANEOUS CEMENT
DELIVERY SYSTEM
STRYKER DRI-LOK
DISPOSABLE CANNULA
STRYKER FORMULA
ARTHROSCOPIC SHAVER
SYSTEM
STRYKER SYSTEM 6 BATTERY
POWERED HEAVY DUTY
SYSTEM
LARYNGEAL MASK LMA
PROSEAL™ (REUSABLE)
90189090
HSAMDB01009
REMOVED IN
VERSION 9
90189090
HSAMDB01009
REMOVED IN
VERSION 9
90183990
HSAMDB01010
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
90189030
REFER TO CRPNS
REMOVED IN
VERSION 9
90200000
HSAMDB01002
REMOVED IN
VERSION 9
RAPIDLAB 1200 CO-OX
38220090
SAMPLE CHAMBER
SIEMENS HEALTHCARE
38220090
DIAGNOSTICS RAPIDLAB 1265
CRITICAL CARE BLOOD GAS
ANALYZER AND ACCESSORIES
HSAMDB01006
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
STRYKER SURGILAV PLUS
IRRIGATION SYSTEM
HARTMANN HYDROFILM &
HYDROFILM PLUS
ABBOTT ARCHITECT
ESTRADIOL ASSAY (LN 7K72)
90189030
REFER TO CRPNS
30051090
HSAMDB01010
38220090
HSAMDB01006
ABBOTT AXSYM
HOMOCYSTEINE ASSAY (LN
5F51 AND 9F84)
STRYKER CORE SYSTEM
38220090
HSAMDB01006
REMOVED IN
VERSION 9
90189090
HSAMDB01009
ICU MICROCLAVE®
NEEDLEFREE IV SYSTEM
CONNECTOR
90183990
HSAMDB01010
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
Page 23
HSAMDB01006
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9
REMOVED IN
VERSION 9