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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 5 of 6

Device	Model / Reference	Registries	Class	Status
Cryostore	CS250S	FDA UDI	Class II	Active
Cryostore	CS25M5	FDA UDI	Class II	Unknown
Tube Set	30-T-SPF	FDA UDI	Class I	Unknown
Injection Spike	IBS-X	FDA UDI	Class I	Unknown
Cryostore	CS50V8S	FDA UDI	Class II	Unknown
Spike Tube Set Adapter	S-FFP12	FDA UDI	Class I	Active
Cryostore	CS500V3	FDA UDI	Class II	Unknown
Cryostore	CS250	FDA UDI	Class II	Active
Cryostore	CS50H	FDA UDI	Class II	Unknown
PermaLife	PL325P	FDA UDI	U	Unknown
Accessories	15-RF12-T	FDA UDI	Class I	Active
TubeSet Adapter	24-T-3T	FDA UDI	Class I	Unknown
Cryostore	CS50F15	FDA UDI	Class II	Unknown
Accessory Set	2S-9M141	FDA UDI	Class I	Unknown
Cryostore	CS250F7	FDA UDI	Class II	Unknown
Protective Cap	PC2-B	FDA UDI	Class I	Unknown
TubeSet Adapter	4S-M40	FDA UDI	Class I	Unknown
Accessories	IBS	FDA UDI	Class I	Active
3ml Syringe, FLL X SCD	15-R3FT	FDA UDI	Class I	Active
Accessory Set	45-F-9M	FDA UDI	Class I	Unknown
NFV x SCD 50ml Syringe	RV50-T15	FDA UDI	Class I	Unknown
O-Wrap	OW0419	FDA UDI	Class I	Unknown
3ml Syringe, FLL X SCD	R3F-T15	FDA UDI	Class I	Active
Spike Adapters	2S-P20	EUDAMEDFDA UDI	Class IIa	Active
CryoStore Freezing Bags	CS50KS	EUDAMEDFDA UDI	Class IIa	Active
Spike Adapters	S-FFP12	EUDAMED	Class IIa	Active
PermaLife™ Cell Culture Bag	PL325-2G	EUDAMEDFDA UDI	Class IIa	Active
CryoStore FLEX Bag	CS20N	EUDAMEDFDA UDI	Class IIa	Active
O-Wrap™ Bag	OW2436	EUDAMEDFDA UDI	Class IIa	Active
CryoStore Freezing Bags	CS250NS	EUDAMEDFDA UDI	Class IIa	Active
Origen Reinforced Dual Lumen Catheter	K113869	FDA 510(k)	Class II	Active
Origen Bladder Holder	K003145	FDA 510(k)	Class II	Active
Cryobag, Model Cb	K021702	FDA 510(k)	U	Active
Origen Dual Lumen Catheter	K003288	FDA 510(k)	Class II	Active
PermaLife™ Cell Culture Bag	PL70K	EUDAMEDFDA UDI	Class IIa	Active
PermaLife™ Cell Culture Bag	PL325M	EUDAMEDFDA UDI	Class IIa	Active
Syringes	15-RF20-T	EUDAMED	Class IIa	Active
PermaLife™ Cell Culture Bag	PL30-2G	EUDAMEDFDA UDI	Class IIa	Active
Cell Connect™	CC1	EUDAMED	Class IIa	Active
TissueVault™ Cell & Tissue Freezing Bag	TV2436	EUDAMEDFDA UDI	Class IIa	Active
CryoStore Freezing Bags	CS250S	EUDAMED	Class IIa	Active
PermaLife™ Cell Culture Bag	PL325K	EUDAMEDFDA UDI	Class IIa	Active
Syringes	RF-T15	EUDAMEDFDA UDI	Class IIa	Active
Syringes	15-R3FT	EUDAMED	Class IIa	Active
CryoStore Freezing Bags	CS50M3	EUDAMED	Class IIa	Active
CryoStore FLEX Bag	CS20V6	EUDAMEDFDA UDI	Class IIa	Active
CryoPur™ Solutions	CP-100	EUDAMED	Class IIa	Active
PermaLife™ Cell Culture Bag	PL70-2G	EUDAMEDFDA UDI	Class IIa	Active
CryoStore Freezing Bags	CS50NS	EUDAMEDFDA UDI	Class IIa	Active
CryoStore 25 Freezing Bag	CS25F	EUDAMED	Class IIa	Active

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.