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) (10)

Premarket Exempt

No Yes

Clear

Cryostore - 10816203020304 Catalog Number :

Device Description : Cryostore 2000 EVA Freezing Bag, 180-450ml, "Y8" Tubing Set, double aseptically Cryostore 2000 EVA Freezing Bag, 180-450ml, "Y8" 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

Cryostore - 10816203020328 Catalog Number :

Device Description : Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "N" Tubing Set, case of 12, singly packed

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020335 Catalog Number :

Device Description : Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "N" tube set, case of 12, double ase Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "N" tube set, case of 12, double aseptic packed in OW

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020342 Catalog Number :

Device Description : Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "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

Cryostore - 10816203020359 Catalog Number :

Device Description : Cryostore 25 EVA Freezing Bag, 10 - 25 ml, "N" tube set, case of 24

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 4

Cryostore - 10816203020366 Catalog Number :

Device Description : Cryostore 500 EVA Freezing Bag, 55 - 100 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 - 10816203020373 Catalog Number :

Device Description : Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "N" Tubing Set, double aseptic pou Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "N" Tubing Set, double aseptic pouched, case of 12

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020380 Catalog Number :

Device Description : Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "N" tube set, case of 12, double as Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "N" tube set, case of 12, double aseptic packed in OW

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020397 Catalog Number :

Device Description : Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "N" Tubing Set, case of 12, singly Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "N" Tubing Set, case of 12, singly packed in triple OW

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020403 Catalog Number :

Device Description : Cryostore 500 EVA 3-Bag set with spike, 55-100ml, 1 set per pouch, case of 8 sets

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

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