BEUDAMED
    FDA Registration Active 🇺🇸 United States

    XPS Disposable Lung Circuit

    Reg #: 3009736925 · FEI: 3009736925 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    XVIVO PERFUSION, INC.
    Registration Number
    3009736925
    FEI Number
    3009736925
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3615 South Huron Street, Suite 201
    City
    Englewood
    State
    CO
    ZIP
    80110
    Country
    US

    Regulatory Submissions

    PMA Number
    P180014

    Owner / Operator

    Firm Name
    XVIVO Perfusion AB
    Operator Number
    10029831
    Address
    Entreprenorsstraket 10
    City
    Mölndal
    State
    Vastra Gotaland
    Postal Code
    43153
    Country
    SE
    Correspondent
    Katrin - Gisselfalt

    Products

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

    Proprietary Names

    XPS Disposable Lung Circuit STEEN Solution XVIVO Lung Cannula Set XPS XVIVO Organ Chamber XVIVO Disposable Kit XVIVO PGM

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility