ITL ASIA PACIFIC SDN. BHD.

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

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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) Supplies, Blood-Bank (KSS) (4)

Premarket Exempt

No Yes

Clear

SampLok® Sampling Kit 16mL - 09555240400536 Catalog Number : A100740

Device Description : SampLok® Sampling Kit (SSK): SSK-Mk2-16mL is used to transfer samples from blood SampLok® Sampling Kit (SSK): SSK-Mk2-16mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.

Device Class : 1

Duns Number: 597723837

Premarket Exempt : No

Product Code : KSS

Prescription Use : Yes

Device Count : 1

SampLok® Sampling Kit 10mL - 09555240400734 Catalog Number : A100750

Device Description : SampLok® Sampling Kit (SSK): SSK-Mk3-10mL is used to transfer samples from blood SampLok® Sampling Kit (SSK): SSK-Mk3-10mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.

Device Class : 1

Duns Number: 597723837

Premarket Exempt : No

Product Code : KSS

Prescription Use : Yes

Device Count : 1

SampLok® Adapter Cap 2 - 09555240401304 Catalog Number : A100718

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; Intended to facilitate collection of blood sample into either culture bottles or vacuum tubes. It is a single use device.

Device Class :

Duns Number: 597723837

Premarket Exempt : No

Product Code : JKA

Prescription Use : Yes

Device Count : 550

SampLok® Adapter Cap 3 - 09555240401526 Catalog Number : A100760

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 culture bottles or vacuum tubes. It is a single use device.

Device Class :

Duns Number: 597723837

Premarket Exempt : No

Product Code : JKA

Prescription Use : Yes

Device Count : 50

SampLok® Adapter Cap 3 Insert - 09555240401533 Catalog Number : A100761

Device Description : SampLok® Adaptor Cap 3 (SAC 3) Insert is an optional accessory to be used with S SampLok® Adaptor Cap 3 (SAC 3) Insert is an optional accessory to be used with SAC 3 to facilitate collection of blood sample into vacuum tube(s). It is a single use device.

Device Class :

Duns Number: 597723837

Premarket Exempt : No

Product Code : JKA

Prescription Use : Yes

Device Count : 70

SampLok® Adapter Cap 3 - 09555240401540 Catalog Number : A100762

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 culture bottles or vacuum tubes. It is a single use device.

Device Class :

Duns Number: 597723837

Premarket Exempt : No

Product Code : JKA

Prescription Use : Yes

Device Count : 700

SampLok® Adapter Cap 3 Insert - 09555240401557 Catalog Number : A100763

Device Class :

Duns Number: 597723837

Premarket Exempt : No

Product Code : JKA

Prescription Use : Yes

Device Count : 1000

SampLok® Sampling Kit 35mL - 09555240403865 Catalog Number : A100752

Device Description : SampLok® Sampling Kit (SSK): SSK-Mk3-35mL is used to transfer samples from blood SampLok® Sampling Kit (SSK): SSK-Mk3-35mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.

Device Class : 1

Duns Number: 597723837

Premarket Exempt : No

Product Code : KSS

Prescription Use : Yes

Device Count : 1

SampLok® Sampling Kit 20mL - 09555240404084 Catalog Number : A100754

Device Description : SampLok® Sampling Kit (SSK) - 20mL is used to transfers samples from blood bags SampLok® Sampling Kit (SSK) - 20mL is used to transfers samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.

Device Class : 1

Duns Number: 597723837

Premarket Exempt : Yes

Product Code : KSS

Prescription Use : Yes

Device Count : 1

SampLok® Adapter Cap Insert - 19555240400014 Catalog Number : A100709

Device Description : SampLok® Adaptor Cap Insert (an optional accessory) can be locked into place ins SampLok® Adaptor Cap Insert (an optional accessory) can be locked into place inside SampLok® Adaptor Cap to facilitate collection of blood sample into vacuum tube(s). It is a single use device.

Device Class :

Duns Number: 597723837

Premarket Exempt : No

Product Code : JKA

Prescription Use : Yes

Device Count : 50

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