BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TherOx DownStream Console, Refurbished

    Reg #: 2030964 · FEI: 3000719308 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    THEROX INC.
    Registration Number
    2030964
    FEI Number
    3000719308
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1641 McGaw Avenue
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US

    Regulatory Submissions

    PMA Number
    P170027

    Owner / Operator

    Firm Name
    ZOLL Medical Corporation
    Operator Number
    1220908
    Address
    269 MILL ROAD
    City
    Chelmsford
    State
    MA
    Postal Code
    01824
    Country
    US

    Products

    Device Name Product Code
    System, Oxygen, Aqueous MWG

    Proprietary Names

    TherOx DownStream Console, Refurbished TherOx DownStream Console TherOx DownStream Cartridge TherOx SSO2 Catheter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility