BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Normothermic preservation system for transplantation of initially unacceptable donor lungs

    Reg #: 1720734 · FEI: 1720734 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IPAX, INC.
    Registration Number
    1720734
    FEI Number
    1720734
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2700 S Raritan St
    City
    Englewood
    State
    CO
    ZIP
    80110
    Country
    US

    Regulatory Submissions

    PMA Number
    P180014

    Owner / Operator

    Firm Name
    IPAX, INC.
    Operator Number
    1720734
    Address
    2700 South Raritan St., --
    City
    Englewood
    State
    CO
    Postal Code
    80110
    Country
    US
    Correspondent
    Jeffery Baldwin

    Products

    Device Name Product Code
    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs PHO

    Proprietary Names

    Normothermic preservation system for transplantation of initially unacceptable donor lungs

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)