BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INOmax DSIR Plus MRI (Delivery System)

    Reg #: 3004531588 · FEI: 3004531588 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    Mallinckrodt Manufacturing LLC
    Registration Number
    3004531588
    FEI Number
    3004531588
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6603 Femrite Dr
    City
    MADISON
    State
    WI
    ZIP
    53718
    Country
    US

    Regulatory Submissions

    510(k) Number
    K143213

    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, Backup Delivery MRO
    Analyzer, Nitric Oxide MRP
    Apparatus, Nitric Oxide Delivery MRN
    Analyzer, Nitrogen Dioxide MRQ

    Proprietary Names

    INOmax DSIR Plus MRI (Delivery System)

    Establishment Types

    Manufacture Medical Device Remanufacture Medical Device