BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Xenotron I Xenon (Xe 133) Gas Dispenser

    Reg #: 3009140376 · FEI: 3009140376 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MALLINCKRODT HOSPITAL PRODUCTS, INC.
    Registration Number
    3009140376
    FEI Number
    3009140376
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    675 McDonnell Blvd
    City
    Hazelwood
    State
    MO
    ZIP
    63042
    Country
    US

    Regulatory Submissions

    510(k) Number
    K843640

    Owner / Operator

    Firm Name
    Mallinckrodt Hospital Products, Inc
    Operator Number
    1925021
    Address
    6603 Femrite Drive
    City
    Madison
    State
    WI
    Postal Code
    53718
    Country
    US
    Correspondent
    David Trueblood

    Products

    Device Name Product Code
    System, Rebreathing, Radionuclide IYT

    Proprietary Names

    Xenotron I Xenon (Xe 133) Gas Dispenser

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198