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OriGen Biomedical, Inc.

United States·US-MF-000018098

Last updated September 17, 2026

Information

Country: United States
Address: 2215, Grand Avenue Parkway, Austin, United States
Website: www.origen.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 512-474-7278
PRRC Contact: Sam Saleh
EUDAMED SRN: US-MF-000018098
FDA FEI Number: 1000160256
DUNS Number: —

Catalogue (263)

Page 3 of 6

Device	Model / Reference	Registries	Class	Status
Cryostore	CS25Y4	FDA UDI	Class II	Active
Cryostore	CS50V4	FDA UDI	Class II	Unknown
TissueVault™ Cell & Tissue Freezing Bag	TV0918	FDA UDI	Class I	Active
Accessories	S-F10	FDA UDI	Class I	Active
Cryostore Harvest Kit	CS750Y12S	FDA UDI	Class II	Unknown
12ml Syringe	R12-C	FDA UDI	Class I	Unknown
Triple Spike Adapter	3S-T100	FDA UDI	Class I	Unknown
Cell Conect	CC2	FDA UDI	Class I	Active
CryoStore	CS500V8	FDA UDI	Class II	Unknown
Cryostore	CS250F1	FDA UDI	Class II	Unknown
Injection Spike	IBS	FDA UDI	Class I	Active
ABS Spike Adapter	ST-A	FDA UDI	Class I	Unknown
Cryostore	CS1000V3	FDA UDI	Class II	Unknown
Accessory Sets	15-RF12-T	FDA UDI	Class I	Active
Accessories	15-R6F-TA	FDA UDI	Class I	Active
CryoStore Freezing Bag	CS25Y4	FDA UDI	Class II	Active
CryoStore Freezing Bag	CS25FP	FDA UDI	Class II	Active
Needle-Free Valves	NFV	FDA UDI	Class I	Unknown
Two 4-way stopcocks	SC-2	FDA UDI	Class I	Unknown
Spike Adapter	S-M50	FDA UDI	Class I	Active
Cryostore	CS250NSWT	FDA UDI	Class II	Unknown
PermaLife	PL30J	FDA UDI	U	Unknown
Accessories	S-F50	FDA UDI	Class I	Active
Cryostore	CS50S-3	FDA UDI	Class II	Unknown
PermaLife™ Cell Culture Bag	PL120-2G	FDA UDI	U	Active
PermaLife	PL750	FDA UDI	U	Unknown
Cryostore	CS250F5	FDA UDI	Class II	Unknown
Cryostore	CS50V9	FDA UDI	Class II	Unknown
PermaLife	PL325	FDA UDI	U	Unknown
Cryostore	CS750V3	FDA UDI	Class II	Unknown
Cryostore	CS250F4S	FDA UDI	Class II	Unknown
PermaLife™ Cell Culture Bag	PL30-2G	FDA UDI	U	Active
Cryostore	CS500i2	FDA UDI	Class II	Unknown
Accessories	S-FFP12	FDA UDI	Class I	Active
CryoStore Freezing Bag	CS28V	FDA UDI	Class II	Active
PermaLife	PL120	FDA UDI	U	Unknown
Cryostore	CS750V3S	FDA UDI	Class II	Unknown
CryoStore Freezing Bag	CS250	FDA UDI	Class II	Unknown
Cryostore	CS500V3S	FDA UDI	Class II	Unknown
PermaLife	PL325L	FDA UDI	U	Unknown
Spike Adapter	S-S50	FDA UDI	Class I	Unknown
Cryobag	CB1936	FDA UDI	U	Unknown
Cryostore	CS750F8	FDA UDI	Class II	Unknown
PermaLife™ Cell Culture Bag	PL70-2G	FDA UDI	U	Active
Cryostore	CS1000NS	FDA UDI	Class II	Unknown
Evolve	EV120	FDA UDI	Class I	Unknown
Adapter Tube Set, Large Bore	HFT	FDA UDI	Class I	Unknown
Cryostore	CS750M2	FDA UDI	Class II	Unknown
Tube Adapter	15-F-T	FDA UDI	Class I	Active
Accessory Set	30-P-6M	FDA UDI	Class I	Unknown

Related Companies

Authorised Representatives

Advena Limited MT

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (20)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 19, 2023	Z-1068-2024	—	open, classified	Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design changes to the syringe barrels and a polypropylene resin change that resulted in loss of gamma compatibility, for accessory set syringes that were gamma sterilized, which resulted in yellowed syringes.
Jan 28, 2021	Z-1409-2021	—	terminated	It was identified that tissue culture bags were incorrectly labeled as free of phthalates.
Jun 24, 2019	Z-0318-2021	—	terminated	The firm has become aware that they have distributed product that was expired.
Aug 21, 2018	Z-0184-2019	—	terminated	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Aug 21, 2018	Z-0181-2019	—	terminated	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Aug 21, 2018	Z-0183-2019	—	terminated	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Aug 21, 2018	Z-0102-2019	—	terminated	The catheter failed the endotoxin testing.
Aug 21, 2018	Z-0182-2019	—	terminated	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Aug 21, 2018	Z-0179-2019	—	terminated	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Aug 21, 2018	Z-0180-2019	—	terminated	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Aug 2, 2017	Z-0021-2018	—	terminated	Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation of the clear extension tube from the hub connection. These adverse events resulted in patient injury (blood loss).
Jan 17, 2017	Z-1227-2019	—	terminated	Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Jan 17, 2017	Z-1231-2019	—	terminated	Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Jan 17, 2017	Z-1230-2019	—	terminated	Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Jan 17, 2017	Z-1228-2019	—	terminated	Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Jan 17, 2017	Z-1229-2019	—	terminated	Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Jan 17, 2017	Z-1232-2019	—	terminated	Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Mar 30, 2015	Z-1456-2015	—	terminated	Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage.
Mar 30, 2015	Z-0269-2019	—	terminated	Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage
Dec 16, 2002	Z-0055-06	—	terminated	Leak between two lumens causes reduced performance.