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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 1 of 6

Device	Model / Reference	Registries	Class	Status
4-Way Stopcock	SC-1	FDA UDI	Class I	Unknown
Evolve	EV120 + F-M12	FDA UDI	Class I	Active
O-Wrap™ Bag	OW0918	FDA UDI	Class I	Active
O-Wrap	OW1430T	FDA UDI	Class I	Unknown
Cryostore	CS500S	FDA UDI	Class II	Unknown
PermaLife	PL120T	FDA UDI	U	Active
PermaLife™ Cell Culture Bag	PL120N	FDA UDI	U	Active
Catheter w/ Blunt Introducer	VV13F	FDA UDI	Class II	Unknown
Cryostore	CS500F1S	FDA UDI	Class II	Unknown
Sterile Syringe	15-R30F-T	FDA UDI	Class I	Unknown
Accessories	VSV	FDA UDI	Class I	Active
PermaLife	PL120T	FDA UDI	U	Unknown
Cryobag	CB1016	FDA UDI	U	Unknown
Spike Adapter	S-38B12	FDA UDI	Class I	Active
Accessories	4S-4M60	FDA UDI	Class I	Active
Cryostore	CS1000NSW	FDA UDI	Class II	Unknown
Accessories	15-R6F-TA	FDA UDI	Class I	Active
Cryostore	CS250FS	FDA UDI	Class II	Unknown
OriGen Biomedical	CC3	FDA UDI	Class I	Unknown
Catheter w/ Blunt Introducer	VV32F	FDA UDI	Class II	Unknown
Cryobag	CB0915	FDA UDI	U	Unknown
Catheter w/ Blunt Introducer	VV28F	FDA UDI	Class II	Unknown
Cryostore	CS50V4SW	FDA UDI	Class II	Unknown
Accessories	R3F-T15	FDA UDI	Class I	Active
Accessories	15-R3FT	FDA UDI	Class I	Active
PermaLife	PL500P	FDA UDI	U	Unknown
CryoStore Freezing Bag	CS25N	FDA UDI	Class II	Active
Spike Adapter	S-M50C	FDA UDI	Class I	Unknown
Cryobag	CB1420	FDA UDI	U	Unknown
Cryostore	CS2000Y5	FDA UDI	Class II	Unknown
Cell Connect	CC35-5MT	FDA UDI	Class I	Unknown
Cryostore	CS1000Y4S	FDA UDI	Class II	Unknown
PermaLife	PL2000P	FDA UDI	U	Unknown
Accessories	S-38B12	FDA UDI	Class I	Active
Cryostore	CS500i2PW	FDA UDI	Class II	Unknown
Female to Female Adapter	F2F	FDA UDI	Class I	Unknown
TissueVault	TV1936	FDA UDI	Class I	Unknown
CryoStore	CS250F21P	FDA UDI	Class II	Unknown
Cryostore	CS250Y12S	FDA UDI	Class II	Unknown
Cryostore	CS750Y10	FDA UDI	Class II	Unknown
Cryostore	CS25XN	FDA UDI	Class II	Active
Cryostore	CS750F1S	FDA UDI	Class II	Unknown
Cryostore	CS50V2	FDA UDI	Class II	Active
PermaLife	PL70	FDA UDI	U	Unknown
60ml Syringe	R60-CS	FDA UDI	Class I	Unknown
CryoStore Freezing Bag	CS30M9	FDA UDI	Class II	Active
Cryostore	CS750V4	FDA UDI	Class II	Unknown
O-Wrap™ Bag	OW0909	FDA UDI	Class I	Active
Cryostore	CS28V	FDA UDI	Class II	Active
Catheter w/ Blunt Introducer	VV16F	FDA UDI	Class II	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.