FDA Device Entity Profile: ORIGEN BIOMEDICAL, INC.

Known Identifiers & Locations

FEI Numbers 1000160256, 3042484745

Owner Operator Numbers 9004483

Locations Covered Austin, TX, US

Registered Establishments (2)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1646848	OriGen Biomedical, Inc.	Austin, TX, US	Manufacture Medical Device	View Details
3042484745	OriGen Biomedical, Inc.	Austin, TX, US	Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0021-2018	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position. Reason: 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).	2017-08-02	Terminated	View Details

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