INOGEN, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30046722753004672275INOGEN, INC.1N2026-01-01859 Ward Drive Suite 200 Goleta CA US 93111

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
00817131020698OxyGo Fit+ Rove 4 - The OxyGo Fit+ Rove 4 Portable Oxygen Concentrator system is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen Rove 4™ Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments.877-466-4632info@inogen.net
00817131020704Oxygo Next Rove 6 - The OxyGo Next - (Rove 6) is a white label version of the Inogen Rove 6™ Portable Oxygen Concentrator system is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen Rove 6™ Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments.877-466-4362info@inogen.net

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
636611398836742K241091SIMEOX 200 Airway Clearance DeviceSDT2024-12-23
636611605858867K230052Inogen Rove 6CAW2023-06-30
636611777611088K222086Inogen Rove 4 Portable Oxygen ConcentratorCAW2022-12-09
636611453686675K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5ACAW2023-04-28
636611436153410K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow MaskBZD2021-07-02
636611679196119K152664TAV SystemONZ2016-12-02
636611517088924K132489INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)CAW2014-06-20
636611180946418K032818INOGEN ONE OXYGEN CONCENTRATORCAW2004-05-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAW52023-06-30
SDT12024-12-23
BZD12021-07-02
ONZ12016-12-02

PMN#

GUDID#

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