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) (6) Container, Empty, For Collection & Processing Of Blood & Blood Components (KSR) (3) Container, Frozen Donor Tissue Storage (LPZ) (1)

Premarket Exempt

No Yes

Clear

Sterile Syringe - 10816203022261 Catalog Number :

Device Description : 30ml syringe on a female luer with 15cm sealed SCD tubing

Device Class : 1

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

CryoStore - 10816203022292 Catalog Number :

Device Description : Cryostore 2000 EVA Freezing Bag, 4-bag Set, 180-450ml, "V8" Tubing Set, double Cryostore 2000 EVA Freezing Bag, 4-bag Set, 180-450ml, "V8" Tubing Set, double aseptically pouched.

Device Class : 2

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Female to Female Adapter - 10816203022322 Catalog Number :

Device Description : One female luer to one male luer with 12cm DMSO resistant tubing, singly aseptic One female luer to one male luer with 12cm DMSO resistant tubing, singly aseptically pouched, case of 50

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

TubeSet Adapter - 10816203022339 Catalog Number :

Device Description : One spike to one female luer with 12cm SCD Tubing, case of 50

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

PermaLife - 10816203022377 Catalog Number :

Device Description : PermaLife Cell Culture Bag, 120ml, "T" Set, 4mil FEP

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Spike Adapter - 10816203022384 Catalog Number :

Device Description : One spike to one spike with 10cm of SCD tubing and pinch clamp, case of 50

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Accessory Set - 10816203022438 Catalog Number :

Device Description : Spike port to six male luers. Singly pouched, 12 per case.

Device Class : 1

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Spike Adapter - 10816203022469 Catalog Number :

Device Description : One spike to one male luer with 50cm DMSO resistant tubing and pinch clamp, case of 50

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203022841 Catalog Number :

Device Description : Cryostore 28 EVA Freezing Bag, 5-20 ml, F tube set, case of 24

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 4

Cryostore - 10816203022865 Catalog Number :

Device Description : Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "N" Tubing Set, case of 24

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 4

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