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

Yes No

Clear

Cryostore - 10816203020755 Catalog Number :

Device Description : CryoStore 1000 EVA Freezing Bag, 3-bag Set, 120 - 275 ml, "V3" Tube Set, case of 12 sets

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020762 Catalog Number :

Device Description : CryoStore 1000 EVA Freezing Bag, 3-bag Set, 120 - 275 ml, "V4" Tube Set, case of 8 sets

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020779 Catalog Number :

Device Description : Cryostore 1000 EVA Freezing Bag, "Y4" Tubing Set, one bag per pouch, double asep Cryostore 1000 EVA Freezing Bag, "Y4" Tubing Set, one bag per pouch, double aseptically pouched, case of 12

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020786 Catalog Number :

Device Description : Cryostore 2000 EVA Freezing Bag, 180-450 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 - 10816203020793 Catalog Number :

Device Description : Cryostore 2000 EVA Freezing Bag, 180-450 ml, "N" Tubing Set, singly pouched, case of 12

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020809 Catalog Number :

Device Description : Cryostore 2000 EVA Freezing Bag, 180-450ml, "N" Tubing Set, double aseptically p Cryostore 2000 EVA Freezing Bag, 180-450ml, "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 - 10816203020816 Catalog Number :

Device Description : Cryostore 2000 EVA Freezing Bag, 180-450ml, "Y5" Tubing Set, case of 24

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203020823 Catalog Number :

Device Description : Cryostore 250 EVA Freezing Bag, 30-70ml, "Standard" Tubing Set, case of 24

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 4

Cryostore - 10816203020830 Catalog Number :

Device Description : Cryostore 250 EVA Freezing Bag, 30-70ml, "F" Tubing Set, case of 24

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 4

Cryostore - 10816203020847 Catalog Number :

Device Description : Cryostore 250 EVA Freezing Bag, 250ml, "F1" 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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