ORIGEN BIOMEDICAL, INC.

Address:7000 Burleson Rd. Bldg D,Austin,TX,78744,US

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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) (3) Container, Frozen Donor Tissue Storage (LPZ) (3) Tube, Tissue Culture (KJG) (3) Accessories, Catheter (KGZ) (1)

Premarket Exempt

No Yes

Clear

Crystore - 10816203022889 Catalog Number :

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

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 4

PermaLife - 10816203022995 Catalog Number :

Device Description : PermaLife Cell Culture Bag, 325ml, "L" Set with 10cm sheath

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

PermaLife - 10816203023008 Catalog Number :

Device Description : PermaLife Cell Culture Bag, 325ml with 10cm sheath

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

PermaLife - 10816203023015 Catalog Number :

Device Description : PermaLife Cell Culture Bag, 325ml, "P" Set, packed with additional PVC spike port

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Accessory Sets - 10816203023046 Catalog Number :

Device Description : 12ml syringe on a female luer with 15cm sealed SCD tubing

Device Class : 1

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Accessory Sets - 10816203023053 Catalog Number :

Device Description : 20ml syringe on a female luer with 15cm sealed SCD tubing

Device Class : 1

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Accessory Sets - 10816203023060 Catalog Number :

Device Description : One 0.2um filter to sealed SCD tubing, sterile

Device Class : 1

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Percutaneous Tray - 10816203023145 Catalog Number :

Device Description : Percutaneous Introducer Tray for Reinforced Dual Lumen Cannula, 13F-32F sizes

Device Class : 1

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

CryoStore - 10816203023152 Catalog Number :

Device Description : CryoStore 500 EVA Freezing Bag, 8-bag set, 55-100ml, "V8" Tube Set

Device Class : 2

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203023169 Catalog Number :

Device Description : Cryostore 50 EVA Freezing Bag, 4-bag Set, 10-30ml, "V8" tubing set

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 1

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