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, Empty, For Collection & Processing Of Blood & Blood Components (KSR) (9) Container, Frozen Donor Tissue Storage (LPZ) (1)

Premarket Exempt

No Yes

Clear

Cryostore - 10816203020410 Catalog Number :

Device Description : Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "N" Tubing Set, case of 24

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 4

Cryostore - 10816203020427 Catalog Number :

Device Description : Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "N" tube set, case of 12, singly packed

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020434 Catalog Number :

Device Description : Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "N" tube set, case of 12, double asep Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "N" tube set, case of 12, double aseptic packed with OW

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020441 Catalog Number :

Device Description : Cryostore 50 EVA 4-Bag Set, 10-30ml, "Standard" Tubing Set, double aseptically p Cryostore 50 EVA 4-Bag Set, 10-30ml, "Standard" Tubing Set, double aseptically pouched with OW, case of 6

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020458 Catalog Number :

Device Description : Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "M2" Tubing Set, case of 24

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 4

Cryostore - 10816203020465 Catalog Number :

Device Description : Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "M2" tube set, case of 12, double a Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "M2" tube set, case of 12, double aseptic packed in O-Wrap

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

CryoBag - 10816203020472 Catalog Number :

Device Description : CryoBag with ports, 10ml Kapton and FEP bag

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020489 Catalog Number :

Device Description : Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "N" tube set, case of 12, singly packed

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020496 Catalog Number :

Device Description : Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "N" tube set, case of 12, double as Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "N" tube set, case of 12, double aseptic packed in O-Wrap

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020502 Catalog Number :

Device Description : Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "N" Tubing Set, case of 12, singly Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "N" Tubing Set, case of 12, singly packed in triple O-Wrap

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

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