FDA.reportPublic FDA data

OriGen Biomedical, Inc.

Matched from indexed company URL: Origen Biomedical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16468481000160256OriGen Biomedical, Inc.1N2026-01-017000 Burleson Rd. Bldg D Austin TX US 78744
30424847453042484745OriGen Biomedical, Inc.1Y2026-01-012215 Grand Avenue Pkwy Austin TX US 78728

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10816203023848Accessories - Needle-free vial spike, DMSO-resistant+1-512-474-7278regulatory@origenbio.com
10816203023916O-Wrap™ Bag - O-Wrap, overwrap pouch for freezing, 9x9cm+1-512-474-7278regulatory@origenbio.com
10816203023923PermaLife™ Cell Culture Bag - PermaLife Cell Culture Bag, 7 mL - no green vent capx+1-512-474-7278regulatory@origenbio.com
10816203023930PermaLife™ Cell Culture Bag - PermaLife Cell Culture Bag, 30 mL - no green vent cap+1-512-474-7278regulatory@origenbio.com
10816203024012TissueVault™ Cell & Tissue Freezing Bag - TissueVault, Cell and Tissue Freezing 9x9cm bag+1-512-474-7278regulatory@origenbio.com
10816203024074Evolve Cell Culture Bag - EVO Bag, 70-120ml Fill Volume, with luer connections and needle free valve with separate female to male tube set with 12cm of tubing+1-512-474-7278regulatory@origenbio.com
10816203024098O-Wrap™ Bag - O-Wrap, overwrap pouch for freezing, 9x18cm+1-512-474-7278regulatory@origenbio.com
10816203024159TissueVault™ Cell & Tissue Freezing Bag - TissueVault, Cell and Tissue Freezing 9x18cm bag+1-512-474-7278regulatory@origenbio.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
769721459837591K021702CRYOBAG, MODEL CBLPZ2002-08-06
3453901459837591K021702CRYOBAG, MODEL CBLPZ2002-08-06
3453901483151941BK180278
769721483151941BK180278
769721535937335BK140116
769721138116192BK030036
3453901138116192BK030036
769721390870020
769721476841500
769721556631764
769721147384064
3453901147384064
3453901390870020
3453901476841500
3453901556631764

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LPZ32002-08-06

PMN#

GUDID#

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