Inogen Inc

FDA Filings

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

USA

NASDAQ

INGN

DUNS 136729634

FDA Registration(s)

• Registration Number: 3015238204
• FEI Number: 3015238204
• Name: Inogen, Inc
• Owner & Operator: INOGEN, INC.
• Contact Address: 326 Bollay Drive ; Goleta CA 93117 US
• Official Correspondent:
  • Mara Korsunsky
  • x-805-5620629-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1225 Commerce Drive ; Richardson, TX 75081 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3015258648
• FEI Number: 3015258648
• Name: Inogen, Inc
• Owner & Operator: INOGEN, INC.
• Contact Address: 326 Bollay Drive ; Goleta CA 93117 US
• Official Correspondent:
  • Mara Korsunsky
  • x-805-5620629-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1 American Road Suite #650; Brooklyn, OH 44144 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3004672275
• FEI Number: 3004672275
• Name: INOGEN, INC.
• Owner & Operator: INOGEN, INC.
• Contact Address: 326 Bollay Drive ; Goleta CA 93117 US
• Official Correspondent:
  • Mara Korsunsky
  • x-805-5620629-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 326 Bollay Dr ; GOLETA, CA 93117 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3009843463
• FEI Number: 3009843463
• Name: Inogen Inc.
• Owner & Operator: INOGEN, INC.
• Contact Address: 326 Bollay Drive ; Goleta CA 93117 US
• Official Correspondent:
  • Mara Korsunsky
  • x-805-5620629-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1125 E Collins Blvd Ste 200 ; Richardson, TX 75081 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00817131020513 INOGEN, INC.	Inogen Rove 6 IO-501	2024-11-01
GUDID 00817131020414 INOGEN, INC.	Inogen Rove 4 IO-401	2024-11-01
GUDID 00817131020384 INOGEN, INC.	7ft O2 Delivery Tube TAV, 1PK RP-1010	2020-03-30
GUDID 00817131020377 INOGEN, INC.	Nasal Interface, 1PK RP-1009	2020-03-30
GUDID 00817131020346 INOGEN, INC.	50ft O2 Delivery Tube TAV, 1PK RP-1012	2020-03-30
GUDID 00817131020339 INOGEN, INC.	25ft O2 Delivery Tube TAV, 1PK RP-1011	2020-03-30
GUDID 00817131020308 INOGEN, INC.	TAV Nasal Interface	2020-03-30
GUDID 00817131020247 INOGEN, INC.	TAV 50ft O2 Delivery Tubing	2020-03-30
GUDID 00817131020230 INOGEN, INC.	TAV 25ft O2 Delivery Tubing	2020-03-30
GUDID 00817131020223 INOGEN, INC.	TAV 7ft O2 Delivery Tubing	2020-03-30
GUDID 00817131020315 INOGEN, INC.	Nasal Interface, 3Pk RP-1000	2020-03-23
GUDID 00817131020261 INOGEN, INC.	1160 AIR DISS Regulator TAV	2020-03-23
GUDID 00817131020254 INOGEN, INC.	1240 O2 DISS Regulator TAV	2020-03-23
GUDID 00817131020216 INOGEN, INC.	Inogen Tidal Assist Ventilator Controller VC-100	2020-03-23
GUDID 00817131020209 INOGEN, INC.	Inogen Tidal Assist Ventilator System VS-100	2020-03-23
PMN K152664 | ONZ INOGEN, INC.	TAV System	2019-08-16
GUDID 00817131020186 INOGEN, INC.	OxyGo NEXT Oxygen Concentrator - Bluetooth 1400-3000u	2019-05-06
GUDID 00817131020162 INOGEN, INC.	Inogen One G5 Oxygen Concentrator - Bluetooth IO-500	2019-04-10
GUDID 00817131020179 INOGEN, INC.	Inogen One G4 Oxygen Concentrator - Bluetooth IO-400	2019-02-07
GUDID 00817131020148 INOGEN, INC.	Inogen At Home Stationary Concentrator GS-100	2018-07-06
GUDID 00817131020131 INOGEN, INC.	Inogen At Home Stationary Concentrator GS-100	2018-07-06
GUDID 00817131020124 INOGEN, INC.	OxyGo Fit IO-400	2018-07-06
GUDID 00817131020117 INOGEN, INC.	Inogen One G4 Oxygen Concentrator IO-400	2018-07-06
GUDID 00817131020100 INOGEN, INC.	OxyGo IO-300	2018-07-06
GUDID 00817131020094 INOGEN, INC.	OxyGo IO-300	2018-07-06
GUDID 00817131020087 INOGEN, INC.	OxyGo IO-300	2018-07-06
GUDID 00817131020070 INOGEN, INC.	OxyGo IO-300	2018-07-06
GUDID 00817131020063 INOGEN, INC.	Inogen One G3 Oxygen Concentrator IO-300	2018-07-06
GUDID 00817131020056 INOGEN, INC.	Inogen One G3 Oxygen Concentrator IO-300	2018-07-06
GUDID 00817131020049 INOGEN, INC.	Inogen One G3 Oxygen Concentrator IO-300	2018-07-06
GUDID 00817131020032 INOGEN, INC.	Inogen One G3 Oxygen Concentrator IO-300	2018-07-06
GUDID 00817131020025 INOGEN, INC.	Inogen One G2 Oxygen Concentrator IO-200	2018-07-06
GUDID 00817131020018 INOGEN, INC.	Inogen One G2 Oxygen Concentrator IO-200	2018-07-06
PMN K132489 | CAW Inogen, Inc [INOGEN, INC.]	Inogen At Home GS 100 Oxygen Concentrator	2014-10-16
PMN K132489 | CAW Inogen, Inc [INOGEN, INC.]	Inogen At Home GS 100 Oxygen Concentrator	2014-10-16
PMN K132489 | CAW Inogen Inc. [INOGEN, INC.]	Inogen At Home GS 100 Oxygen Concentrator	2014-10-16
PMN K132489 | CAW INOGEN, INC.	Inogen At Home GS 100 Oxygen Concentrator	2014-10-16
PMN K132489 INOGEN, INC.	INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)	2014-06-20
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	OxyGo	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	OxyGo	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	OxyGo NEXT	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	OxyGo NEXT	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	OxyGo Fit	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	OxyGo Fit	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	OxyGo Fit BLUETOOTH	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	OxyGo Fit BLUETOOTH	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	INOGEN ONE OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	INOGEN ONE OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	INOGEN ONE G5 OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	INOGEN ONE G5 OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	INOGEN ONE G4 OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	INOGEN ONE G4 OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	INOGEN ONE G4 BLUETOOTH OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	INOGEN ONE G4 BLUETOOTH OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	INOGEN ONE G3 OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	INOGEN ONE G3 OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	INOGEN ONE G2 OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW Inogen, Inc [INOGEN, INC.]	INOGEN ONE G2 OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW Inogen Inc. [INOGEN, INC.]	OxyGo	2004-06-16
PMN K032818 | CAW Inogen Inc. [INOGEN, INC.]	OxyGo NEXT	2004-06-16
PMN K032818 | CAW Inogen Inc. [INOGEN, INC.]	OxyGo Fit	2004-06-16
PMN K032818 | CAW Inogen Inc. [INOGEN, INC.]	OxyGo Fit BLUETOOTH	2004-06-16
PMN K032818 | CAW Inogen Inc. [INOGEN, INC.]	INOGEN ONE OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW Inogen Inc. [INOGEN, INC.]	INOGEN ONE G5 OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW Inogen Inc. [INOGEN, INC.]	INOGEN ONE G4 OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW Inogen Inc. [INOGEN, INC.]	INOGEN ONE G4 BLUETOOTH OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW Inogen Inc. [INOGEN, INC.]	INOGEN ONE G3 OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW Inogen Inc. [INOGEN, INC.]	INOGEN ONE G2 OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW INOGEN, INC.	OxyGo	2004-06-16
PMN K032818 | CAW INOGEN, INC.	OxyGo NEXT	2004-06-16
PMN K032818 | CAW INOGEN, INC.	OxyGo Fit	2004-06-16
PMN K032818 | CAW INOGEN, INC.	OxyGo Fit BLUETOOTH	2004-06-16
PMN K032818 | CAW INOGEN, INC.	INOGEN ONE OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW INOGEN, INC.	INOGEN ONE G5 OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW INOGEN, INC.	INOGEN ONE G4 OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW INOGEN, INC.	INOGEN ONE G4 BLUETOOTH OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW INOGEN, INC.	INOGEN ONE G3 OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 | CAW INOGEN, INC.	INOGEN ONE G2 OXYGEN CONCENTRATOR	2004-06-16
PMN K032818 INOGEN, INC.	INOGEN ONE OXYGEN CONCENTRATOR	2004-05-13

Related Finance Registrations

NCAGE Code	58H15	INOGEN, INC
CAGE Code	58H15	INOGEN, INC
S.A.M. Registration	58H15 [136729634]	INOGEN, INC
SEC	0001294133	Inogen Inc of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019061011450	Southhampton,United Kingdom -> Los Angeles, California	ALUMINIUM TUBE	13 PCS
2018081650572	Yantian,China (Mainland) -> Long Beach, California	POWER SUPPLY CORD	70 CTN
2018062815327	Hong Kong,Hong Kong -> Los Angeles, California	FINGERTIP PULSE OXIMETER	5 CTN
2018061834112	Hong Kong,Hong Kong -> Los Angeles, California	FINGERTIP PULSE OXIMETER	5 CTN
2018020219319	Hong Kong,Hong Kong -> Los Angeles, California	AUTO INPUT DC CABLE	99 CTN
2018012433263	Hong Kong,Hong Kong -> Los Angeles, California	AUTO INPUT DC CABLE	99 CTN
2018012350207	Hong Kong,Hong Kong -> Los Angeles, California	AUTO INPUT DC CABLE	99 CTN
2018012242769	Hong Kong,Hong Kong -> Los Angeles, California	AUTO INPUT DC CABLE	99 CTN