BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Inogen, Inc

    Reg #: 3019385742 · FEI: 3009843463 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    15
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    Inogen, Inc
    Registration Number
    3019385742
    FEI Number
    3009843463
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    600 Shiloh Rd.
    City
    Plano
    State
    TX
    ZIP
    75074
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132489

    Owner / Operator

    Firm Name
    INOGEN, INC.
    Operator Number
    9064201
    Address
    859 Ward Drive, Suite 200
    City
    Goleta
    State
    CA
    Postal Code
    93111
    Country
    US
    Correspondent
    Elias Cury

    Products

    Device Name Product Code
    Generator, Oxygen, Portable CAW
    Intra-Pulmonary Percussive Vibration (Ipv) Devices SDT
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    Inogen At Home GS 100 Oxygen Concentrator Inogen Rove 4 Portable Oxygen Concentrator Inogen Rove 6 Portable Oxygen Concentrator SIMEOX 200 Airway Clearance Device INOGEN ONE G3 OXYGEN CONCENTRATOR OxyGo Fit INOGEN ONE G4 OXYGEN CONCENTRATOR INOGEN ONE OXYGEN CONCENTRATOR INOGEN ONE G5 OXYGEN CONCENTRATOR INOGEN ONE G4 BLUETOOTH OXYGEN CONCENTRATOR OxyGo OxyGo NEXT OxyGo Fit BLUETOOTH INOGEN ONE G2 OXYGEN CONCENTRATOR Aurora

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Remanufacture Medical Device