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) (5) Container, Frozen Donor Tissue Storage (LPZ) (4) Tube, Tissue Culture (KJG) (1)

Premarket Exempt

No Yes

Clear

PermaLife - 10816203023411 Catalog Number :

Device Description : PermaLife Cell Culture Bag, 2000ml, "P2" Set, packed with additional NFV cover

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203023428 Catalog Number : CS500NP

Device Description : Cryostore 500 EVA Freezing Bag, 55-100ml, "N" Tube Set, singly packed

Device Class : 2

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Accessories - 10816203023435 Catalog Number :

Device Description : Two male luers to one spike port and one female luer with 20cm SCD tubing with p Two male luers to one spike port and one female luer with 20cm SCD tubing with pinch clamps.

Device Class : 1

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

CryoStore - 10816203023558 Catalog Number : CS20N

Device Description : CryoStore 20 EVA 5-Chamber Freezing Bag, 20-30ml, "N" Tube Set

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : No

Device Count : 4

CryoStore - 10816203023565 Catalog Number : CS20F

Device Description : CryoStore 20 EVA 5-Chamber Freezing Bag, 20-30ml, "F" Tube Set

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : No

Device Count : 4

CryoStore - 10816203023572 Catalog Number : CS20NS

Device Description : CryoStore 20 EVA 5-Chamber Freezing Bag, 20-30ml, "NS" Tube Set

Device Class : 2

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : No

Device Count : 1

CryoStore - 10816203023589 Catalog Number : CS20V6

Device Description : CryoStore multiple bag set, six 20 EVA freezing bags, 20-30ml, "V6" Tube Set

Device Class : 2

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : No

Device Count : 1

PermaLife - 10816203023596 Catalog Number : PL30T

Device Description : PermaLife Cell Culture bag, 30ml, with SCD Tubing

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : No

Device Count : 1

PermaLife - 10816203023602 Catalog Number : PL120T

Device Description : PermaLife Cell Culture Bag, 120ml, with SCD Tubing

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : No

Device Count : 1

PermaLife - 10816203023619 Catalog Number : PL240T

Device Description : PermaLife Cell Culture bag, 240ml, with SCD Tubing

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : No

Device Count : 1

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