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 Number: 1646848
• FEI Number: 1000160256
• Name: OriGen Biomedical, Inc.
• Owner & Operator: ORIGEN BIOMEDICAL
• Contact Address: 7000 Burleson Rd., Bldg D --; Austin TX 78744 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 7000 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	Device	Date
GUDID 20816203023753 ORIGEN BIOMEDICAL, INC.	CryoStore Freezing Bag CS250KS	2024-12-16
GUDID 20816203023449 ORIGEN BIOMEDICAL, INC.	Accessories 15-R6F-TA	2024-12-16
GUDID 20816203022824 ORIGEN BIOMEDICAL, INC.	Accessories 80HAS	2024-12-16
GUDID 20816203021100 ORIGEN BIOMEDICAL, INC.	CryoStore Freezing Bag CS30M9	2024-12-16
GUDID 10816203023718 ORIGEN BIOMEDICAL, INC.	PermaLife™ Cell Culture Bag PL2000K	2024-12-16
GUDID 10816203023701 ORIGEN BIOMEDICAL, INC.	PermaLife™ Cell Culture Bag PL1000K	2024-12-16
GUDID 10816203023695 ORIGEN BIOMEDICAL, INC.	PermaLife™ Cell Culture Bag PL750K	2024-12-16
GUDID 10816203023688 ORIGEN BIOMEDICAL, INC.	PermaLife™ Cell Culture Bag PL500K	2024-12-16
GUDID 10816203023671 ORIGEN BIOMEDICAL, INC.	PermaLife™ Cell Culture Bag PL120K	2024-12-16
GUDID 10816203023664 ORIGEN BIOMEDICAL, INC.	PermaLife™ Cell Culture Bag PL70K	2024-12-16
GUDID 10816203023657 ORIGEN BIOMEDICAL, INC.	PermaLife™ Cell Culture Bag PL30K	2024-12-16
GUDID 20816203022183 ORIGEN BIOMEDICAL, INC.	Tube Set	2024-12-13
GUDID 10816203022148 ORIGEN BIOMEDICAL, INC.	Catheter w/ Blunt Introducer	2024-12-13
GUDID 10816203022124 ORIGEN BIOMEDICAL, INC.	Catheter w/ Blunt Introducer	2024-12-13
GUDID 10816203022100 ORIGEN BIOMEDICAL, INC.	Catheter w/ Blunt Introducer	2024-12-13
GUDID 10816203022094 ORIGEN BIOMEDICAL, INC.	Catheter w/ Blunt Introducer	2024-12-13
GUDID 10816203022056 ORIGEN BIOMEDICAL, INC.	Catheter w/ Blunt Introducer	2024-12-13
GUDID 10816203020632 ORIGEN BIOMEDICAL, INC.	Spike Adapter	2024-12-13
GUDID 20816203023319 ORIGEN BIOMEDICAL, INC.	OriGen Biomedical CC3	2024-12-12
GUDID 20816203022435 ORIGEN BIOMEDICAL, INC.	Accessory Set	2024-12-12
GUDID 20816203022299 ORIGEN BIOMEDICAL, INC.	CryoStore	2024-12-12
GUDID 10816203022070 ORIGEN BIOMEDICAL, INC.	Catheter w/ Blunt Introducer	2024-12-12
GUDID 10816203021646 ORIGEN BIOMEDICAL, INC.	Injection Spike	2024-12-12
GUDID 10816203020663 ORIGEN BIOMEDICAL, INC.	Cryobag	2024-12-12
GUDID 10816203020625 ORIGEN BIOMEDICAL, INC.	Triple Spike Adapter	2024-12-12
GUDID 10816203020472 ORIGEN BIOMEDICAL, INC.	CryoBag	2024-12-12
GUDID 10816203020113 ORIGEN BIOMEDICAL, INC.	Injection Spike	2024-12-12
GUDID 10816203022193 ORIGEN BIOMEDICAL, INC.	TubeSet Adapter	2024-04-23
GUDID 10816203020656 ORIGEN BIOMEDICAL, INC.	Cryobag	2024-04-23
GUDID 10816203021462 ORIGEN BIOMEDICAL, INC.	TissueVault	2023-04-11
GUDID 00816203022615 ORIGEN BIOMEDICAL, INC.	O-Wrap	2023-04-11
GUDID 00816203022608 ORIGEN BIOMEDICAL, INC.	O-Wrap	2023-04-11
GUDID 00816203022592 ORIGEN BIOMEDICAL, INC.	O-Wrap	2023-04-11
GUDID 00816203022585 ORIGEN BIOMEDICAL, INC.	O-Wrap	2023-04-11
GUDID 00816203022257 ORIGEN BIOMEDICAL, INC.	O-Wrap	2023-04-11
GUDID 00816203022226 ORIGEN BIOMEDICAL, INC.	O-Wrap	2023-04-11
GUDID 00816203022202 ORIGEN BIOMEDICAL, INC.	O-Wrap	2023-04-11
GUDID 10816203022810 ORIGEN BIOMEDICAL, INC.	TissueVault	2023-04-10
GUDID 10816203022803 ORIGEN BIOMEDICAL, INC.	TissueVault	2023-04-10
GUDID 10816203022797 ORIGEN BIOMEDICAL, INC.	TissueVault	2023-04-10
GUDID 10816203021479 ORIGEN BIOMEDICAL, INC.	TissueVault	2023-04-10
GUDID 10816203022780 ORIGEN BIOMEDICAL, INC.	TissueVault	2023-04-04
GUDID 10816203022575 ORIGEN BIOMEDICAL, INC.	O-Wrap	2023-04-04
GUDID 20816203023746 ORIGEN BIOMEDICAL, INC.	CryoStore CS750KS	2023-03-23
GUDID 20816203023739 ORIGEN BIOMEDICAL, INC.	CryoStore CS500KS	2023-03-23
GUDID 20816203023722 ORIGEN BIOMEDICAL, INC.	CryoStore CS50KS	2023-03-23
GUDID 20816203020936 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 20816203020905 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 20816203020899 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 20816203020875 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 20816203020844 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 20816203020837 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 20816203020820 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 20816203020783 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 20816203020721 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 20816203020714 ORIGEN BIOMEDICAL, INC.	CryoStore	2022-06-17
GUDID 20816203020455 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 20816203020417 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 20816203020363 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 20816203020356 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020922 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020915 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020885 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020816 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020809 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020793 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020779 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020762 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020755 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020748 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020731 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020700 ORIGEN BIOMEDICAL, INC.	Cryobag	2022-06-17
GUDID 10816203020694 ORIGEN BIOMEDICAL, INC.	Cryobag	2022-06-17
GUDID 10816203020687 ORIGEN BIOMEDICAL, INC.	Cryobag	2022-06-17
GUDID 10816203020526 ORIGEN BIOMEDICAL, INC.	Cryostore Harvest Kit	2022-06-17
GUDID 10816203020519 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020502 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020496 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020489 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020465 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020441 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020434 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020427 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020403 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020397 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020380 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020373 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020342 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020335 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020328 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020304 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020298 ORIGEN BIOMEDICAL, INC.	Cryostore	2022-06-17
GUDID 10816203020182 ORIGEN BIOMEDICAL, INC.	PermaLife	2022-06-17
GUDID 10816203020175 ORIGEN BIOMEDICAL, INC.	PermaLife	2022-06-17
GUDID 10816203020168 ORIGEN BIOMEDICAL, INC.	PermaLife	2022-06-17
GUDID 10816203020151 ORIGEN BIOMEDICAL, INC.	PermaLife	2022-06-17
GUDID 10816203020144 ORIGEN BIOMEDICAL, INC.	PermaLife	2022-06-17
GUDID 10816203020137 ORIGEN BIOMEDICAL, INC.	PermaLife	2022-06-17
GUDID 10816203020090 ORIGEN BIOMEDICAL, INC.	Evolve	2022-06-17
GUDID 10816203020083 ORIGEN BIOMEDICAL, INC.	Evolve	2022-06-17
PMN BK180278 | KSR OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	OriGen Cryostore Multi-Chamber Freezing Bags	2018-12-12
PMN BK140116 | KSR OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	OriGen Transfer Bag	2016-11-18
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Vial spike with needle-free valve, pack of 10	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Two spikes to one spike port with 20cm SCD tubing and pinch clamps	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Two spike ports to one spike with 16cm SCD tubing	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Two male luers to one male luer with 17cm of DMSO resistant tubing	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Two male luers to one female luer with 17cm of DMSO resistant tubing	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Two 4-way stopcocks adhesive bonded, individually pouched	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Three spikes to sealed tubing with 100cm of SCD tubing and pinch clamps	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Spike port to six male luers. Singly pouched, 12 per case.	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Spike extender set, resistant to 80% DMSO, case of 24	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	RBC tube set, sealed tube with spike, FLL, and spike port	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Protective Cap for female luer	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One spike with male to male luer	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One spike to one spike with 50cm of SCD tubing and pinch clamp	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One spike to one spike with 10cm of SCD tubing and pinch clamp	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One spike to one spike port and two female luers with 12cm SCD tubing and pinch clamps, case of 20	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One spike to one male luer with 50cm SCD tubing and roller clamp	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One spike to one male luer with 50cm DMSO resistant tubing and pinch clamp	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One spike to one male luer with 150cm tubing and roller clamp	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One spike to one male luer with 10cm DMSO resistant tubing and pinch clamp	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One spike to one female luer with 50cm DMSO resistant tubing and pinch clamp	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One spike to one female luer with 15cm DMSO resistant tubing and pinch clamp	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One spike to one female luer with 12cm SCD Tubing, case of 50	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One spike to one female luer with 10cm DMSO resistant tubing and pinch clamp	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One spike to one 3/8? barb with 12cm DMSO resistant tubing, case of 25	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One spike to a needle-free valve to one spike and two male luers with 40cm tubing and roller clamps	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One spike and vented drip chamber to nine male luers with 140cm SCD tubing and pinch clamps	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One female luer with 15cm of SCD tubing	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One female luer to one male luer with 12cm DMSO resistant tubing	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One female luer to one male luer with 12cm DMSO resistant tubing, singly aseptically pouched	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One female luer to eight spikes with 100cm of SCD tubing and pinch clamps, case of 20	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	One 0.2um filter to sealed SCD tubing, sterile	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Needle-free valve with caps, case of 10	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Knob style, non-vented cap for male luer, case of 100	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Four spikes to four male luers with 60cm SCD tubing, roller and pinch clamps	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Female to female luer adapter	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	DMSO-Resistant Bag Spike with non- ahdered needle injection port	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	DMSO-Resistant Bag Spike with needle injection port	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	DMSO-Resistant Bag Spike with needle injection port , bulk packed	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	DMSO resistant Bag Spike w/ Needle-Free Injection Port	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Adapter tube set, 4 bag spikes x 1 Male luer, 40cm	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	6ml syringe with a female luer with 15cm sealed SCD tubing, case of 25	2016-09-21
KJG 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 25	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	60ml syringe with a cap, double aseptically pouched, case of 20	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	60ml syringe on a needle-free valve with 15cm SCD tubing with porous vent plug, case of 25	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	60ml syringe on a female luer with 15cm sealed SCD tubing	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	4x12cm SCD tubing tube set	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	4-way stopcock, individually pouched	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	3ml syringe on a female luer with 15cm sealed SCD tubing	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	3ml syringe on a female luer with 15cm of SCD tubing	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	20ml syringe on a female luer with 15cm sealed SCD tubing	2016-09-21
KJG 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
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	12ml syringe, double aseptically pouched, case of 12	2016-09-21
KJG OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	12ml syringe on a female luer with 15cm sealed SCD tubing	2016-09-21
KJG 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 clamps	2016-09-21
PMN K113869 Origen Biomedical, Inc.	ORIGEN REINFORCED DUAL LUMEN CATHETER	2012-07-26
KSD OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Tube Sealer	2012-06-25
KJA OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	PermaLife	2011-04-25
KJA OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Evolve	2011-04-25
PMN K021702 | LPZ OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Permalife	2007-11-06
PMN K021702 | LPZ OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Cryobag	2007-11-06
PMN BK030036 | KSR OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	PermaLife	2007-11-06
PMN BK030036 | KSR OriGen Biomedical, Inc. [ORIGEN BIOMEDICAL]	Cryostore	2007-11-06
PMN K021702 ORIGEN BIOMEDICAL, INC.	CRYOBAG, MODEL CB	2002-08-06
PMN K003288 ORIGEN BIOMEDICAL, INC.	ORIGEN DUAL LUMEN CATHETER	2001-06-08
PMN K003145 ORIGEN BIOMEDICAL, INC.	ORIGEN BLADDER HOLDER	2001-04-20

Related Finance Registrations

NCAGE Code	433G8	ORIGEN BIOMEDICAL, INC.
CAGE Code	433G8	ORIGEN BIOMEDICAL, INC.
S.A.M. Registration	433G8 [625272232]	ORIGEN BIOMEDICAL, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018110840772	Shanghai ,China (Mainland) -> Los Angeles, California	20 B2 BROMOBUTYL RUBBER STOPPER	2 PKG