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

Tube, Tissue Culture (KJG) (7) Flask, Tissue Culture (KJA) (2) Container, Frozen Donor Tissue Storage (LPZ) (1)

Premarket Exempt

No Yes

Clear

PermaLife - 00816203021762 Catalog Number :

Device Description : PermaLife Cell Culture Bag, 120ml, with 10cm sheath

Device Class : U

Duns Number: 625272232

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Tube Adapter - 10816203020007 Catalog Number :

Device Description : One female luer with 15cm of SCD tubing, case of 50

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

TubeSet Adapter - 10816203020014 Catalog Number :

Device Description : 4x12cm SCD tubing tube set

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Spike Coupler - 10816203020021 Catalog Number :

Device Description : Two spikes to one spike port with 20cm SCD tubing and pinch clamps

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Manifold Set - 10816203020038 Catalog Number :

Device Description : Four spikes to four male luers with 60cm SCD tubing, roller and pinch clamps

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Needle Free Spike - 10816203020045 Catalog Number :

Device Description : DMSO resistant Bag Spike w/ Needle-Free Injection Port

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Cell Connect - 10816203020052 Catalog Number :

Device Description : Two spikes to a 3-way stopcock, 60ml syringe and needle-free valve to four male Two spikes to a 3-way stopcock, 60ml syringe and needle-free valve to four male luers with 70cm SCD tubing and pinch clamps.

Device Class : 1

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Cell Conect - 10816203020069 Catalog Number :

Device Description : One spike and male luer to a 3-way stopcock, 60ml syringe and needle-free valve One spike and male luer to a 3-way stopcock, 60ml syringe and needle-free valve to four male luers with 70cm SCD tubing and pinch clamps.

Device Class : 1

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJG

Prescription Use : Yes

Device Count : 1

Evolve - 10816203020083 Catalog Number :

Device Description : 1000ml Cell Culture Bag, EVO film, "N" tube set, case of 12

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : Yes

Device Count : 1

Evolve - 10816203020090 Catalog Number :

Device Description : 120ml EVO cell culture bag, with female luers Additional, female to male tube ac 120ml EVO cell culture bag, with female luers Additional, female to male tube accessory set 12cm in length

Device Class :

Duns Number: 625272232

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : Yes

Device Count : 1

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