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

Device, General Purpose, Microbiology, Diagnostic (LIB) (2) Supplies, Blood-Bank (KSS) (1) Tray, Surgical, Instrument (FSM) (1) Tubes, Vials, Systems, Serum Separators, Blood Collection (JKA) (1)

Premarket Exempt

No Yes

Clear

ITL Essentials™ Sharps Passing Tray, Non-sterile - 19555240401196 Catalog Number : A500102

Device Description : ITL Essentials™ Sharps Passing Tray is intended for safe transfer of sharp instr ITL Essentials™ Sharps Passing Tray is intended for safe transfer of sharp instruments such as surgical scalpels and capped syringes during surgery. For single use only

Device Class : 1

Duns Number: 597723837

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 115

SampLok® Adapter Cap 2 - 19555240401219 Catalog Number : A100715

Device Description : The SampLok® Adapter Cap has a Luer thread which facilitates attachment with com The SampLok® Adapter Cap has a Luer thread which facilitates attachment with commonly available multi-sample Luer adaptor; It is intended to facilitate collection of blood sample into either a culture bottle or standard vacuum blood tubes. It is a single use device.

Device Class :

Duns Number: 597723837

Premarket Exempt : No

Product Code : JKA

Prescription Use : Yes

Device Count : 40

Segment Sampler (SEG) - 19555240401332 Catalog Number : A200200

Device Description : SEG is intended to aid extraction of a biological fluid sample from a segmented SEG is intended to aid extraction of a biological fluid sample from a segmented piece of tubing.

Device Class :

Duns Number: 597723837

Premarket Exempt : No

Product Code : KSS

Prescription Use : Yes

Device Count : 1

Transfer Cap Set - 19555240401400 Catalog Number : A100730

Device Description : Transfer Cap Set is a single-use device intended to aid sterile transfer of flui Transfer Cap Set is a single-use device intended to aid sterile transfer of fluids between blood culture bottles and vacuum tubes. The device is for use by trained laboratory staff, in a laboratory.

Device Class : 1

Duns Number: 597723837

Premarket Exempt : Yes

Product Code : LIB

Prescription Use : Yes

Device Count : 1

Safety SubCulture Unit 2 (SCU2) - 19555240401431 Catalog Number : A100722

Device Description : SCU2 is a needleless device used to obtain samples from blood culture bottles an SCU2 is a needleless device used to obtain samples from blood culture bottles and to prevent the risk of a potential needlestick injury.

Device Class :

Duns Number: 597723837

Premarket Exempt : Yes

Product Code : LIB

Prescription Use : Yes

Device Count : 1

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