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

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF) (6) Container, Empty, For Collection & Processing Of Blood & Blood Components (KSR) (2) Tube, Tissue Culture (KJG) (2)

Premarket Exempt

Yes No

Clear

Catheter w/ Blunt Introducer - 10816203022056 Catalog Number :

Device Description : ECMO Reinforced Dual Lumen Cannula, 13F

Device Class : 2

Duns Number: 625272232

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Catheter w/ Blunt Introducer - 10816203022070 Catalog Number :

Device Description : ECMO Reinforced Dual Lumen Cannula, 16F

Device Class : 2

Duns Number: 625272232

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Catheter w/ Blunt Introducer - 10816203022094 Catalog Number :

Device Description : ECMO Reinforced Dual Lumen Cannula, 19F

Device Class : 2

Duns Number: 625272232

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Catheter w/ Blunt Introducer - 10816203022100 Catalog Number :

Device Description : ECMO Reinforced Dual Lumen Cannula, 23F

Device Class : 2

Duns Number: 625272232

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Catheter w/ Blunt Introducer - 10816203022124 Catalog Number :

Device Description : ECMO Reinforced Dual Lumen Cannula, 28F

Device Class : 2

Duns Number: 625272232

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Catheter w/ Blunt Introducer - 10816203022148 Catalog Number :

Device Description : ECMO Reinforced Dual Lumen Cannula, 32F

Device Class : 2

Duns Number: 625272232

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Tube Set - 10816203022186 Catalog Number :

Device Description : RBC tube set, sealed tube with spike, FLL, and spike port

Device Class : 1

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

TubeSet Adapter - 10816203022193 Catalog Number :

Device Description : Adapter tube set, 4 bag spikes x 1 Male luer, 40cm

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Cryostore - 10816203022230 Catalog Number :

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

Device Class :

Duns Number: 625272232

Premarket Exempt : No

Product Code : KSR

Prescription Use : Yes

Device Count : 4

Cryostore - 10816203022247 Catalog Number :

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