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) (2) Container, Empty, For Collection & Processing Of Blood & Blood Components (KSR) (1)

Premarket Exempt

No Yes

Clear

PermaLife - 10816203023626 Catalog Number : PL325T

Device Description : PermaLife Cell Culture Bag, 325ml, with SCD Tubing

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : No

Device Count : 1

PermaLife - 10816203023633 Catalog Number : PL750T

Device Description : PermaLife Cell Culture bag, 750ml, with SCD Tubing

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : No

Device Count : 1

CryoStore - 10816203023640 Catalog Number : CS250S

Device Description : CryoStore 250 EVA Freezing Bag, 30-70ml, "K" Tube Set, double aseptically packed

Device Class : 2

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

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