Origen Biomedical Inc

FDA Filings

This page includes the latest FDA filings for Origen Biomedical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1646848
FEI Number1000160256
NameOriGen Biomedical, Inc.
Owner & OperatorORIGEN BIOMEDICAL
Contact Address7000 Burleson Rd., Bldg D --
Austin TX 78744 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7000 Burleson Rd. Bldg D
Austin, TX 78744 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
ORIGEN BIOMEDICAL, INC.
 PermaLife™ Cell Culture Bag PL120-2G2025-06-26
ORIGEN BIOMEDICAL, INC.
 PermaLife™ Cell Culture Bag PL120N2025-06-26
ORIGEN BIOMEDICAL, INC.
 Accessories F-8S1002025-06-26
ORIGEN BIOMEDICAL, INC.
 CryoStore Freezing Bag CS50M32025-06-26
ORIGEN BIOMEDICAL, INC.
 CryoStore Freezing Bag CS30M92025-06-26
ORIGEN BIOMEDICAL, INC.
 CryoStore Freezing Bag CS5002025-06-26
ORIGEN BIOMEDICAL, INC.
 CryoStore Freezing Bag CS2502025-06-26
ORIGEN BIOMEDICAL, INC.
 CryoStore Freezing Bag CS50N2025-06-26
ORIGEN BIOMEDICAL, INC.
 CryoStore Freezing Bag CS502025-06-26
ORIGEN BIOMEDICAL, INC.
 CryoStore Freezing Bag CS25XN2025-06-26
ORIGEN BIOMEDICAL, INC.
 CryoStore Freezing Bag CS25N2025-06-26
ORIGEN BIOMEDICAL, INC.
 CryoStore Freezing Bag CS25F2025-06-26
ORIGEN BIOMEDICAL, INC.
 TissueVault™ Cell & Tissue Freezing Bag TV09182025-06-26
ORIGEN BIOMEDICAL, INC.
 Accessories S-38B122025-06-26
ORIGEN BIOMEDICAL, INC.
 PermaLife™ Cell Culture Bag PL70-2G2025-06-26
ORIGEN BIOMEDICAL, INC.
 PermaLife™ Cell Culture Bag PL30M2025-06-26
ORIGEN BIOMEDICAL, INC.
 O-Wrap™ Bag OW09182025-06-26
ORIGEN BIOMEDICAL, INC.
 Evolve Cell Culture Bag EV120 + F-M122025-06-26
ORIGEN BIOMEDICAL, INC.
 CryoStore Freezing Bag CS28V2025-06-26
ORIGEN BIOMEDICAL, INC.
 CryoStore Freezing Bag CS25Y42025-06-26
ORIGEN BIOMEDICAL, INC.
 TissueVault™ Cell & Tissue Freezing Bag TV09092025-06-26
ORIGEN BIOMEDICAL, INC.
 Accessories S-M502025-06-26
ORIGEN BIOMEDICAL, INC.
 Accessories S-FFP122025-06-26
ORIGEN BIOMEDICAL, INC.
 Accessories S-F502025-06-26
ORIGEN BIOMEDICAL, INC.
 Accessories S-F102025-06-26
ORIGEN BIOMEDICAL, INC.
 Accessories R3F-T152025-06-26
ORIGEN BIOMEDICAL, INC.
 PermaLife™ Cell Culture Bag PL30-2G2025-06-26
ORIGEN BIOMEDICAL, INC.
 PermaLife™ Cell Culture Bag PL07-2G2025-06-26
ORIGEN BIOMEDICAL, INC.
 O-Wrap™ Bag OW09092025-06-26
ORIGEN BIOMEDICAL, INC.
 CryoStore Freezing Bag CS25FP2025-06-26
ORIGEN BIOMEDICAL, INC.
 Accessories 15-RF20-T2025-06-26
ORIGEN BIOMEDICAL, INC.
 Accessories 15-RF12-T2025-06-26
ORIGEN BIOMEDICAL, INC.
 Accessories 15-R6F-TA2025-06-26
ORIGEN BIOMEDICAL, INC.
 Accessories 15-R3FT2025-06-26
ORIGEN BIOMEDICAL, INC.
 Accessories VSV2025-06-26
ORIGEN BIOMEDICAL, INC.
 Accessories 80HAS2025-06-26
ORIGEN BIOMEDICAL, INC.
 Accessories 4S-4M602025-06-26
ORIGEN BIOMEDICAL, INC.
 Accessories IBS2025-06-26
ORIGEN BIOMEDICAL, INC.
 Tube Set Adapter 2025-06-18
ORIGEN BIOMEDICAL, INC.
 Cell Conect 2025-06-18
ORIGEN BIOMEDICAL, INC.
 Cell Connect 2025-06-18
ORIGEN BIOMEDICAL, INC.
 Spike Adapter 2025-06-18
ORIGEN BIOMEDICAL, INC.
 Injection Spike 2025-06-18
ORIGEN BIOMEDICAL, INC.
 Needle Free Spike 2025-06-18
ORIGEN BIOMEDICAL, INC.
 Manifold Set 2025-06-18
ORIGEN BIOMEDICAL, INC.
 Spike Coupler 2025-06-18
ORIGEN BIOMEDICAL, INC.
 CryoStore Freezing Bag CS250KS2024-12-16
ORIGEN BIOMEDICAL, INC.
 Accessories 15-R6F-TA2024-12-16
ORIGEN BIOMEDICAL, INC.
 Accessories 80HAS2024-12-16
ORIGEN BIOMEDICAL, INC.
 CryoStore Freezing Bag CS30M92024-12-16
ORIGEN BIOMEDICAL, INC.
 PermaLife™ Cell Culture Bag PL2000K2024-12-16
ORIGEN BIOMEDICAL, INC.
 PermaLife™ Cell Culture Bag PL1000K2024-12-16
ORIGEN BIOMEDICAL, INC.
 PermaLife™ Cell Culture Bag PL750K2024-12-16
ORIGEN BIOMEDICAL, INC.
 PermaLife™ Cell Culture Bag PL500K2024-12-16
ORIGEN BIOMEDICAL, INC.
 PermaLife™ Cell Culture Bag PL120K2024-12-16
ORIGEN BIOMEDICAL, INC.
 PermaLife™ Cell Culture Bag PL70K2024-12-16
ORIGEN BIOMEDICAL, INC.
 PermaLife™ Cell Culture Bag PL30K2024-12-16
ORIGEN BIOMEDICAL, INC.
 Tube Set 2024-12-13
ORIGEN BIOMEDICAL, INC.
 Catheter w/ Blunt Introducer 2024-12-13
ORIGEN BIOMEDICAL, INC.
 Catheter w/ Blunt Introducer 2024-12-13
ORIGEN BIOMEDICAL, INC.
 Catheter w/ Blunt Introducer 2024-12-13
ORIGEN BIOMEDICAL, INC.
 Catheter w/ Blunt Introducer 2024-12-13
ORIGEN BIOMEDICAL, INC.
 Catheter w/ Blunt Introducer 2024-12-13
ORIGEN BIOMEDICAL, INC.
 Spike Adapter 2024-12-13
ORIGEN BIOMEDICAL, INC.
 OriGen Biomedical CC32024-12-12
ORIGEN BIOMEDICAL, INC.
 Accessory Set 2024-12-12
ORIGEN BIOMEDICAL, INC.
 CryoStore 2024-12-12
ORIGEN BIOMEDICAL, INC.
 Catheter w/ Blunt Introducer 2024-12-12
ORIGEN BIOMEDICAL, INC.
 Injection Spike 2024-12-12
ORIGEN BIOMEDICAL, INC.
 Cryobag 2024-12-12
ORIGEN BIOMEDICAL, INC.
 Triple Spike Adapter 2024-12-12
ORIGEN BIOMEDICAL, INC.
 CryoBag 2024-12-12
ORIGEN BIOMEDICAL, INC.
 Injection Spike 2024-12-12
ORIGEN BIOMEDICAL, INC.
 TubeSet Adapter 2024-04-23
ORIGEN BIOMEDICAL, INC.
 Cryobag 2024-04-23
ORIGEN BIOMEDICAL, INC.
 TissueVault 2023-04-11
ORIGEN BIOMEDICAL, INC.
 O-Wrap 2023-04-11
ORIGEN BIOMEDICAL, INC.
 O-Wrap 2023-04-11
ORIGEN BIOMEDICAL, INC.
 O-Wrap 2023-04-11
ORIGEN BIOMEDICAL, INC.
 O-Wrap 2023-04-11
ORIGEN BIOMEDICAL, INC.
 O-Wrap 2023-04-11
ORIGEN BIOMEDICAL, INC.
 O-Wrap 2023-04-11
ORIGEN BIOMEDICAL, INC.
 O-Wrap 2023-04-11
ORIGEN BIOMEDICAL, INC.
 TissueVault 2023-04-10
ORIGEN BIOMEDICAL, INC.
 TissueVault 2023-04-10
ORIGEN BIOMEDICAL, INC.
 TissueVault 2023-04-10
ORIGEN BIOMEDICAL, INC.
 TissueVault 2023-04-10
ORIGEN BIOMEDICAL, INC.
 TissueVault 2023-04-04
ORIGEN BIOMEDICAL, INC.
 O-Wrap 2023-04-04
ORIGEN BIOMEDICAL, INC.
 CryoStore CS750KS2023-03-23
ORIGEN BIOMEDICAL, INC.
 CryoStore CS500KS2023-03-23
ORIGEN BIOMEDICAL, INC.
 CryoStore CS50KS2023-03-23
ORIGEN BIOMEDICAL, INC.
 PermaLife 2022-06-17
ORIGEN BIOMEDICAL, INC.
 PermaLife 2022-06-17
ORIGEN BIOMEDICAL, INC.
 PermaLife 2022-06-17
ORIGEN BIOMEDICAL, INC.
 PermaLife 2022-06-17
ORIGEN BIOMEDICAL, INC.
 PermaLife 2022-06-17
ORIGEN BIOMEDICAL, INC.
 PermaLife 2022-06-17
ORIGEN BIOMEDICAL, INC.
 Evolve 2022-06-17
ORIGEN BIOMEDICAL, INC.
 Evolve 2022-06-17
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
OriGen Cryostore Multi-Chamber Freezing Bags2018-12-12
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
OriGen Transfer Bag2016-11-18
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Vial spike with needle-free valve, pack of 102016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Two spikes to one spike port with 20cm SCD tubing and pinch clamps2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Two spike ports to one spike with 16cm SCD tubing2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Two male luers to one male luer with 17cm of DMSO resistant tubing2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Two male luers to one female luer with 17cm of DMSO resistant tubing2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Two 4-way stopcocks adhesive bonded, individually pouched2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Three spikes to sealed tubing with 100cm of SCD tubing and pinch clamps2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Spike port to six male luers. Singly pouched, 12 per case.2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Spike extender set, resistant to 80% DMSO, case of 242016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
RBC tube set, sealed tube with spike, FLL, and spike port2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Protective Cap for female luer2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One spike with male to male luer2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One spike to one spike with 50cm of SCD tubing and pinch clamp2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One spike to one spike with 10cm of SCD tubing and pinch clamp2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One spike to one spike port and two female luers with 12cm SCD tubing and pinch clamps, case of 202016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One spike to one male luer with 50cm SCD tubing and roller clamp2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One spike to one male luer with 50cm DMSO resistant tubing and pinch clamp2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One spike to one male luer with 150cm tubing and roller clamp2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One spike to one male luer with 10cm DMSO resistant tubing and pinch clamp2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One spike to one female luer with 50cm DMSO resistant tubing and pinch clamp2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One spike to one female luer with 15cm DMSO resistant tubing and pinch clamp2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One spike to one female luer with 12cm SCD Tubing, case of 502016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One spike to one female luer with 10cm DMSO resistant tubing and pinch clamp2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One spike to one 3/8? barb with 12cm DMSO resistant tubing, case of 252016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One spike to a needle-free valve to one spike and two male luers with 40cm tubing and roller clamps2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One spike and vented drip chamber to nine male luers with 140cm SCD tubing and pinch clamps2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One female luer with 15cm of SCD tubing2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One female luer to one male luer with 12cm DMSO resistant tubing2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One female luer to one male luer with 12cm DMSO resistant tubing, singly aseptically pouched2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One female luer to eight spikes with 100cm of SCD tubing and pinch clamps, case of 202016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
One 0.2um filter to sealed SCD tubing, sterile2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Needle-free valve with caps, case of 102016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Knob style, non-vented cap for male luer, case of 1002016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Four spikes to four male luers with 60cm SCD tubing, roller and pinch clamps2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Female to female luer adapter2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
DMSO-Resistant Bag Spike with non- ahdered needle injection port2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
DMSO-Resistant Bag Spike with needle injection port2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
DMSO-Resistant Bag Spike with needle injection port , bulk packed2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
DMSO resistant Bag Spike w/ Needle-Free Injection Port2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Adapter tube set, 4 bag spikes x 1 Male luer, 40cm2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
6ml syringe with a female luer with 15cm sealed SCD tubing, case of 252016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
6ml syringe on a needle-free valve with 15cm SCD tubing (tubing is plugged with a breathable vent) , case of 252016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
60ml syringe with a cap, double aseptically pouched, case of 202016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
60ml syringe on a needle-free valve with 15cm SCD tubing with porous vent plug, case of 252016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
60ml syringe on a female luer with 15cm sealed SCD tubing2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
4x12cm SCD tubing tube set2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
4-way stopcock, individually pouched2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
3ml syringe on a female luer with 15cm sealed SCD tubing2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
3ml syringe on a female luer with 15cm of SCD tubing2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
20ml syringe on a female luer with 15cm sealed SCD tubing2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
2 spikes to a 3-way stopcock; 60ml syringe, needle-free valve to 4 male luers w/ 70cm SCD tubing, pinch clamps.2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
12ml syringe, double aseptically pouched, case of 122016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
12ml syringe on a female luer with 15cm sealed SCD tubing2016-09-21
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
1 spike, male luer to a 3-way stopcock; 60ml syringe, needle-free valve to 4 male luers, 70cm SCD tubing, pinch clamps2016-09-21
Origen Biomedical, Inc.
ORIGEN REINFORCED DUAL LUMEN CATHETER2012-07-26
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Tube Sealer2012-06-25
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
PermaLife2011-04-25
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Evolve2011-04-25
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Permalife2007-11-06
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Cryobag2007-11-06
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
PermaLife2007-11-06
OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]
Cryostore2007-11-06
ORIGEN BIOMEDICAL, INC.
CRYOBAG, MODEL CB2002-08-06
ORIGEN BIOMEDICAL, INC.
ORIGEN DUAL LUMEN CATHETER2001-06-08
ORIGEN BIOMEDICAL, INC.
ORIGEN BLADDER HOLDER2001-04-20

Related Finance Registrations
NCAGE Code433G8ORIGEN BIOMEDICAL, INC.
CAGE Code433G8ORIGEN BIOMEDICAL, INC.
S.A.M. Registration433G8 [625272232]ORIGEN BIOMEDICAL, INC.
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2018110840772Shanghai ,China (Mainland) -> Los Angeles, California20 B2 BROMOBUTYL RUBBER STOPPER2 PKG
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