Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1646848

FEI Number

1000160256

Entity Name

OriGen Biomedical, Inc.

City/State/Country

Austin, TX, US

Establishment Address

7000 Burleson Rd. Bldg D, Austin, TX 78744, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ORIGEN BIOMEDICAL, INC. (Owner Number: 9004483)

Owner / Operator Contact Address

7000 Burleson Rd., Bldg D, --, Austin, TX 78744, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K021702

PMA Number

N/A

All Registered Proprietary Names

PermaLife® Cell Culture Bag, Evolve Cell Culture Bag Tube Sealer CryoStore Multi-Chamber Bag Accessories PermaLife® Cell Culture Bag

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KJA	Flask, Tissue Culture	Hematology	Class 1	864.2240	2011-04-25
KSD	Device, Heat-Sealing	Hematology	Class 1	864.9750	2012-06-25
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2018-12-12
KJG	Tube, Tissue Culture	Pathology	Class 1	864.3010	2016-09-21
LPZ	Container, Frozen Donor Tissue Storage	Unknown	Class U	N/A	2007-11-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ORIGEN BIOMEDICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3042484745	OriGen Biomedical, Inc.	Austin, TX, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2018	OriGen Biomedical, Inc.	2	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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1646848. Last updated year: 2026. Please use registration number 1646848 when referencing this establishment in official correspondence.