ITL ASIA PACIFIC SDN. BHD.

Address:Plot 17B, Lorong Bemban 2,Batu Gajah Perak,MY

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Tubes, Vials, Systems, Serum Separators, Blood Collection (JKA) (6) Needle, Hypodermic, Single Lumen (FMI) (4) Supplies, Blood-Bank (KSS) (2) Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (LXG) (1)

Premarket Exempt

No Yes

Clear

SampLok® System with Hinged Lid - 19555240400045 Catalog Number : A100648

Device Description : SampLok® Hinged Lid (Wide Bore), Clear, Assembled with PC Luer with Isoprene Sle SampLok® Hinged Lid (Wide Bore), Clear, Assembled with PC Luer with Isoprene Sleeve, Bulk, Non-Sterile; Intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests

Device Class :

Duns Number: 597723837

Premarket Exempt : No

Product Code : FMI, JKA

Prescription Use : Yes

Device Count : 700

SampLok® With Hinged Lid - 19555240400069 Catalog Number : A100422

Device Description : SampLok® Hinged Lid 11-18 (Wider Bore), Clear, Bulk, Non-Sterile; Intended as a SampLok® Hinged Lid 11-18 (Wider Bore), Clear, Bulk, Non-Sterile; Intended as a needle holder for a Luer adapter needle to vacuum blood collection tube.

Device Class :

Duns Number: 597723837

Premarket Exempt : No

Product Code : JKA

Prescription Use : Yes

Device Count : 700

SampLok® System with Hinged Lid - 19555240400076 Catalog Number : A100643

Device Description : SampLok® Hinged Lid (Wide Bore), Clear, Assembled with PP Luer with Isoprene Sle SampLok® Hinged Lid (Wide Bore), Clear, Assembled with PP Luer with Isoprene Sleeve, Bulk, Non-Sterile; Intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests

Device Class :

Duns Number: 597723837

Premarket Exempt : No

Product Code : FMI, JKA

Prescription Use : Yes

Device Count : 700

TiMO™ Tube Management Holder - 19555240400083 Catalog Number :

Device Description : TiMO™ is intended as a sample test tube holder to assist with the management of TiMO™ is intended as a sample test tube holder to assist with the management of the sample tubes during blood collection.

Device Class :

Duns Number: 597723837

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 1500

DonorCare® Needle Guard Small Channel - 19555240400137 Catalog Number : A100100

Device Description : DonorCare Needle Guard is intended to aid in the prevention of accidental needle DonorCare Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.

Device Class : 1

Duns Number: 597723837

Premarket Exempt : No

Product Code : KSS

Prescription Use : Yes

Device Count : 1000

DonorCare® Needle Guard Large Channel - 19555240400151 Catalog Number : A100150

Device Description : DonorCare® Needle Guard is intended to aid in the prevention of accidental needl DonorCare® Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.

Device Class : 1

Duns Number: 597723837

Premarket Exempt : No

Product Code : KSS

Prescription Use : Yes

Device Count : 1000

Platypus® AV Fistula Needle Guard - 19555240400168 Catalog Number : A100360

Device Description : Platypus® is intended for use in the prevention of accidental needle stick injur Platypus® is intended for use in the prevention of accidental needle stick injuries upon completion of hemodialysis and apheresis procedures;Platypus® has been designed to allow the winged needle assembly to be pulled into the Platypus® and once fully engaged, the winged needle assembly is locked in, thus shielding and locking the needle and preventing needle exposure;Platypus® is supplied bulk, non-sterile.

Device Class :

Duns Number: 597723837

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1200

SampLok® - 19555240400175 Catalog Number : A100400

Device Description : SampLok without Lid (TitanPro), TR Blue, Bulk, Non-Sterile; It is intended as a SampLok without Lid (TitanPro), TR Blue, Bulk, Non-Sterile; It is intended as a needle holder for a Luer adapter needle to vacuum blood collection tube.

Device Class :

Duns Number: 597723837

Premarket Exempt : No

Product Code : JKA

Prescription Use : Yes

Device Count : 1000

SampLok® Adapter Cap Kit - 19555240400199 Catalog Number : A100704

Device Description : SampLok® Adaptor Cap Kit (SampLok® Adaptor Cap, clear, assembled with PP Luer, b SampLok® Adaptor Cap Kit (SampLok® Adaptor Cap, clear, assembled with PP Luer, bulk, non-sterile); It is intended to facilitate collection of blood samples into either a culture bottle or standard vacuum blood tubes.

Device Class :

Duns Number: 597723837

Premarket Exempt : No

Product Code : FMI, JKA

Prescription Use : Yes

Device Count : 300

SampLok® Adapter Cap - 19555240400205 Catalog Number : A100706

Device Description : SampLok® Adaptor Cap, Clear, Bulk, Non-sterile; Intended to facilitate collectio SampLok® Adaptor Cap, Clear, Bulk, Non-sterile; Intended to facilitate collection of blood sample into either a culture bottle or standard vacuum blood tubes

Device Class :

Duns Number: 597723837

Premarket Exempt : No

Product Code : JKA

Prescription Use : Yes

Device Count : 350

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