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

Container, Frozen Donor Tissue Storage (LPZ) (5) Container, Empty, For Collection & Processing Of Blood & Blood Components (KSR) (4) Tube, Tissue Culture (KJG) (1)

Premarket Exempt

No Yes

Clear

Spike Adapter - 10816203020632 Catalog Number :

Device Description : One spike to a needle-free valve to one spike and two male luers with 40cm tubin One spike to a needle-free valve to one spike and two male luers with 40cm tubing and roller clamps

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Cryobag - 10816203020656 Catalog Number :

Device Description : Cryobag, 09x15, Kapton/FEP

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Cryobag - 10816203020663 Catalog Number :

Device Description : Cryobag, 10x16, Kapton/FEP

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Cryobag - 10816203020687 Catalog Number :

Device Description : Cryobag, 14 x 20, Kapton/FEP

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 10

Cryobag - 10816203020694 Catalog Number :

Device Description : Cryobag, 19 x 36, Kapton/FEP

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Cryobag - 10816203020700 Catalog Number :

Device Description : Cryobag, 14 x 28, Kapton/FEP

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

CryoStore - 10816203020717 Catalog Number :

Device Description : Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F21" Tubing Set, with IBS and male Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F21" Tubing Set, with IBS and male luer cap, singly packed, case of 12

Device Class : 2

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020724 Catalog Number :

Device Description : Cryostore 1000 EVA Freezing Bag, 120-275ml, "N" Tubing Set, case of 24

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 4

Cryostore - 10816203020731 Catalog Number :

Device Description : Cryostore 1000 EVA Freezing Bag, 120-275ml, "N" Tubing Set, double aseptically Cryostore 1000 EVA Freezing Bag, 120-275ml, "N" Tubing Set, double aseptically pouched, case of 12

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020748 Catalog Number :

Device Description : Cryostore 1000 EVA Freezing Bag, 120-275ml, "N" Tubing Set, double aseptically p Cryostore 1000 EVA Freezing Bag, 120-275ml, "N" Tubing Set, double aseptically pouched in OW, case of 12

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

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