BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Mallinckrodt Manufacturing LLC

    Reg #: 3004531588 · FEI: 3004531588 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    22
    Establishment Types
    3
    Classifications
    9

    Registration Details

    Registration Name
    Mallinckrodt Manufacturing LLC
    Registration Number
    3004531588
    FEI Number
    3004531588
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6603 Femrite Dr
    City
    MADISON
    State
    WI
    ZIP
    53718
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222930

    Owner / Operator

    Firm Name
    Mallinckrodt Hospital Products IP Limited
    Operator Number
    10050702
    Address
    Damastown Industrial Estate
    City
    Mulhuddart
    State
    Dublin
    Postal Code
    15
    Country
    IE

    Products

    Device Name Product Code
    Apparatus, Nitric Oxide Delivery MRN
    Analyzer, Nitric Oxide MRP
    Analyzer, Nitrogen Dioxide MRQ
    System, Rebreathing, Radionuclide IYT
    Apparatus, Nitric Oxide, Backup Delivery MRO
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Container, Specimen, Urine, Drugs Of Abuse, Over The Counter MPQ
    Tubing, Pressure And Accessories BYX
    Ventilatory Effort Recorder MNR

    Proprietary Names

    Evolve Nitric Oxide Delivery System INOmax DSIR (Delivery System) INOmax DS (Delivery System) Xenotron I Xenon (Xe 133) Gas Dispenser INOmax DSIR Plus INOMAX DS DELIVERY SYSTEM INOvent Adapter , Gas Sample Tee 15M Adapter (fits 8 mm ID Tubing) Adapter , Cuff, 22 mm ID X 22 mm ID Adapter , 22F X 15M 15 M Adapter (fits 4.5 mm ID Tubing) Adapter , 22 mm OD X 10 mm OD Adapter , 22M/15F X 22M/15F Pediatric Extension, 15 mm, 6 inches One-Way Valve, 22F X 22M Sample Tee, O2 Tubing Adapter, 90 Degree Sample Port INOmax DSIR Plus MRI (Delivery System) Xenotron - Stopcock/Interconnect Accessory INOblender INOBLENDER

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)