ORIGEN BIOMEDICAL, INC.

Address:7000 Burleson Rd. Bldg D,Austin,TX,78744,US

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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

Tube, Tissue Culture (KJG) (8) Container, Empty, For Collection & Processing Of Blood & Blood Components (KSR) (2)

Premarket Exempt

No Yes

Clear

Cryostore - 10816203020519 Catalog Number :

Device Description : Cryostore 750 EVA Freezing Bag, 80-190ml, 3- Bag set with "V3" Tube Set, double Cryostore 750 EVA Freezing Bag, 80-190ml, 3- Bag set with "V3" Tube Set, double aseptically pouched, case of 8 sets

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore Harvest Kit - 10816203020526 Catalog Number :

Device Description : Cryostore Harvest Kit, 750 EVA Freezing Bag, "Y12" Tubing Set, case of 12, double packed

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

TubeSetAdapter - 10816203020557 Catalog Number :

Device Description : One female luer to one male luer with 12cm DMSO resistant tubing

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

3ml Syringe, FLL X SCD - 10816203020564 Catalog Number :

Device Description : 3ml BD syringe on a female luer with 15cm of SCD tubing

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

60ml Syringe, FLL X SCD - 10816203020571 Catalog Number :

Device Description : 60ml syringe on a female luer with 15cm sealed SCD tubing

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Spike Adapter - 10816203020588 Catalog Number :

Device Description : One spike to one male luer with 150cm tubing and roller clamp

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

TubeSet Adapter - 10816203020595 Catalog Number :

Device Description : Two male luers to one female luer with 17cm of DMSO resistant tubing

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

TubeSet Adapter - 10816203020601 Catalog Number :

Device Description : Two male luers to one male luer with 17cm of DMSO resistant tubing

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Tube Set Adapter - 10816203020618 Catalog Number :

Device Description : Two spike ports to one spike with 16cm SCD tubing

Device Class : 1

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Triple Spike Adapter - 10816203020625 Catalog Number :

Device Description : Three spikes to sealed tubing with 100cm of SCD tubing and pinch clamps

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

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