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Inogen, Inc.

United States·US-MF-000027368

Last updated September 17, 2026

Information

Country: United States
Address: 859, Ward Drive, Goleta, United States
Website: www.inogen.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 8556946643
PRRC Contact: Greg Porter
EUDAMED SRN: US-MF-000027368
FDA FEI Number: 3004672275
DUNS Number: 136729634

Catalogue (41)

Device	Model / Reference	Registries	Class	Status
TAV 25ft O2 Delivery Tubing	10-09890-XX-01	FDA UDI	Class II	Active
Oxygo Next Rove 6	OxyGo Next Rove 6 (10-13402-00-01)	FDA UDI	Class II	Active
Inogen One G4 Oxygen Concentrator	630	FDA UDI	Class II	Active
Inogen One G2 Oxygen Concentrator	1260	FDA UDI	Class II	Active
Inogen One G3 Oxygen Concentrator	1050	FDA UDI	Class II	Active
1160 AIR DISS Regulator TAV	10-09841-XX-01	FDA UDI	Class II	Active
Inogen One G5 Oxygen Concentrator - Bluetooth	1260 Bluetooth	FDA UDI	Class II	Active
Nasal Interface, 1PK	RP-1009	FDA UDI	Class II	Active
Inogen One G3 Oxygen Concentrator	840	FDA UDI	Class II	Active
OxyGo Fit	630	FDA UDI	Class II	Active
TAV 7ft O2 Delivery Tubing	10-09889-XX-01	FDA UDI	Class II	Active
Inogen One G3 Oxygen Concentrator	1050	FDA UDI	Class II	Active
OxyGo	1050	FDA UDI	Class II	Active
TAV 50ft O2 Delivery Tubing	10-09891-XX-01	FDA UDI	Class II	Active
50ft O2 Delivery Tube TAV, 1PK	RP-1012	FDA UDI	Class II	Active
7ft O2 Delivery Tube TAV, 1PK	RP-1010	FDA UDI	Class II	Active
Simeox 200	SIMEOX-2 B	FDA UDI	Class II	Unknown
Tub25	TUB-25	FDA UDI	Class II	Unknown
OxyGo NEXT Oxygen Concentrator - Bluetooth	1260 Bluetooth	FDA UDI	Class II	Active
25ft O2 Delivery Tube TAV, 1PK	RP-1011	FDA UDI	Class II	Active
Simeox 200	SIMEOX-2	FDA UDI	Class II	Unknown
Inogen Tidal Assist Ventilator System	VS-100	FDA UDI	Class II	Active
Inogen One G3 Oxygen Concentrator	840	FDA UDI	Class II	Active
Inogen At Home Stationary Concentrator	CE	FDA UDI	Class II	Active
Tub10	TUB10	FDA UDI	Class II	Unknown
Inogen One G2 Oxygen Concentrator	1260	FDA UDI	Class II	Active
TAV Nasal Interface	10-09815-XX-01	FDA UDI	Class II	Active
OxyGo Fit+ Rove 4	OxyGo Fit+ (10-13401-00-01)	FDA UDI	Class II	Active
OxyGo	1050	FDA UDI	Class II	Active
Inogen At Home Stationary Concentrator	NCE	FDA UDI	Class II	Active
Inogen Tidal Assist Ventilator Controller	VC-100	FDA UDI	Class II	Active
OxyGo	840	FDA UDI	Class II	Active
1240 O2 DISS Regulator TAV	10-09779-XX-01	FDA UDI	Class II	Active
Nasal Interface, 3Pk	RP-1000	FDA UDI	Class II	Active
OxyGo	840	FDA UDI	Class II	Active
Inogen Rove 4 Portable Oxygen Concentrator	K222086	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Inogen At Home Oxygen Concentrator (aka Inogen At Home)	K132489	FDA 510(k)	Class II	Active
SIMEOX 200 Airway Clearance Device	K241091	FDA 510(k)	Class II	Active
Inogen One Oxygen Concentrator	K032818	FDA 510(k)	Class II	Active
Inogen One G4 System	IS-400	EUDAMEDFDA UDI	Class IIb	Active
Inogen Rove 6	IS-501	EUDAMEDFDA UDI	Class IIb	Active

Related Companies

Authorised Representatives

Inogen Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 1, 2005	Z-1368-05	—	terminated	Firm plans to upgrade all units to correct situations that could lead to interuption in oxygen delivery.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Inogen, Inc Plano, TX · US FEI 3009843463