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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 2 of 6

Device	Model / Reference	Registries	Class	Status
Cryostore	CS500NP	FDA UDI	Class II	Unknown
Injection Spike	IBS-B	FDA UDI	Class I	Unknown
Cryostore	CS500V2P	FDA UDI	Class II	Unknown
PermaLife™ Cell Culture Bag	PL07-2G	FDA UDI	U	Active
Cryobag	CB1428	FDA UDI	U	Unknown
Cryostore	CS1000V4	FDA UDI	Class II	Unknown
Cryostore	CS500F16	FDA UDI	Class II	Unknown
Spike Adapter	S-F50	FDA UDI	Class I	Active
Cryostore	CS500i	FDA UDI	Class II	Unknown
Percutaneous Kit	PCTa	FDA UDI	Class I	Unknown
PermaLife	PL07	FDA UDI	U	Unknown
TubeSet Adapter	F-S12	FDA UDI	Class I	Unknown
TubeSetAdapter	12-F-M	FDA UDI	Class I	Unknown
6ml Syringe, NFV x SCD	RV-T15	FDA UDI	Class I	Unknown
CryoBag	CB10K2	FDA UDI	U	Unknown
CryoStore Freezing Bag	CS25F	FDA UDI	Class II	Active
CryoStore Freezing Bag	CS50N	FDA UDI	Class II	Active
PVC Transfer Bag	10-200	FDA UDI	Class II	Unknown
Vial Spike with Needle-Free Valve	VSV	FDA UDI	Class I	Active
Cryostore	CS50F4S	FDA UDI	Class II	Unknown
PVC Transfer Bag	10-200-2	FDA UDI	Class II	Unknown
Spike Adapter	S-F10	FDA UDI	Class I	Active
Spike Adapter	SU-M50	FDA UDI	Class I	Unknown
Cryostore	CS250F4	FDA UDI	Class II	Unknown
Accessories	80HAS	FDA UDI	Class I	Active
Accessory Sets	15-T-FA	FDA UDI	Class I	Unknown
Evolve	EV3000N	FDA UDI	Class I	Active
PermaLife	PL30	FDA UDI	U	Unknown
Accessory Sets	15-RF20-T	FDA UDI	Class I	Active
Catheter w/ Blunt Introducer	VV19F	FDA UDI	Class II	Unknown
Cryostore	CS50M3	FDA UDI	Class II	Active
Cryostore	CS25F	FDA UDI	Class II	Active
Accessories	80HAS	FDA UDI	Class I	Active
Cryostore	CS250F	FDA UDI	Class II	Unknown
PVC Transfer Bag	10-200-CS25	FDA UDI	Class II	Unknown
Spike Adapter	SM	FDA UDI	Class I	Unknown
Cryostore	CS2000NP	FDA UDI	Class II	Unknown
Needle Free Spike	CBS	FDA UDI	Class I	Active
Cryostore	CS250SW	FDA UDI	Class II	Unknown
Cryostore	CS500SW	FDA UDI	Class II	Unknown
Cryostore	CS250Y12P	FDA UDI	Class II	Unknown
CryoStore Freezing Bag	CS50	FDA UDI	Class II	Active
Female to Female Adapter	F-M12	FDA UDI	Class I	Unknown
Cryostore	CS25V2	FDA UDI	Class II	Unknown
Cryostore	CS2000	FDA UDI	Class II	Unknown
Accessories	F-8S100	FDA UDI	Class I	Active
Evolve	EV1000N	FDA UDI	Class I	Active
Spike Adapter	40-S-V-SMM	FDA UDI	Class I	Unknown
Spike Adapter	S-S10	FDA UDI	Class I	Active
Percutaneous Tray	PCT	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.