FDA.reportPublic FDA data

INOGEN, INC.

Matched from indexed company URL: 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
30193857423009843463Inogen, Inc1Y2026-01-01600 Shiloh Rd. Plano TX US 75074
30098434633009843463Inogen Inc.1N2020-04-251125 E Collins Blvd Ste 200 Richardson TX US 75081
30152382043015238204Inogen, Inc1Y2020-04-251225 Commerce Drive Richardson TX US 75081
30152586483015258648Inogen, Inc1N2020-04-251 American Road Suite #650 Brooklyn OH US 44144

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
2935461398836742K241091SIMEOX 200 Airway Clearance DeviceSDT2024-12-23
636611605858867K230052Inogen Rove 6CAW2023-06-30
2935461605858867K230052Inogen Rove 6CAW2023-06-30
636611777611088K222086Inogen Rove 4 Portable Oxygen ConcentratorCAW2022-12-09
2935461777611088K222086Inogen Rove 4 Portable Oxygen ConcentratorCAW2022-12-09
636611453686675K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5ACAW2023-04-28
2935461436153410K203347Sleep 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
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
2258161517088924K132489INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)CAW2014-06-20
2935461517088924K132489INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)CAW2014-06-20
2265291517088924K132489INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)CAW2014-06-20
1460101517088924K132489INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)CAW2014-06-20
636611517088924K132489INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)CAW2014-06-20
2265291180946418K032818INOGEN ONE OXYGEN CONCENTRATORCAW2004-05-13
2935461180946418K032818INOGEN ONE OXYGEN CONCENTRATORCAW2004-05-13
2258161180946418K032818INOGEN ONE OXYGEN CONCENTRATORCAW2004-05-13
636611180946418K032818INOGEN ONE OXYGEN CONCENTRATORCAW2004-05-13
1460101180946418K032818INOGEN ONE OXYGEN CONCENTRATORCAW2004-05-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAW152023-06-30
SDT22024-12-23
BZD22021-07-02
ONZ12016-12-02

PMN#

GUDID#

41 records. Showing 1-40. Next