BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MALLINCKRODT HOSPITAL PRODUCTS INC.

    Reg #: 3014527933 · FEI: 3014074925 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    6

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    Registration Details

    Registration Name
    MALLINCKRODT HOSPITAL PRODUCTS INC.
    Registration Number
    3014527933
    FEI Number
    3014074925
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    440 Route 22 East, Suite 302
    City
    Bridgewater
    State
    NJ
    ZIP
    08807
    Country
    US

    Regulatory Submissions

    510(k) Number
    K143213
    PMA Number
    P860003

    Owner / Operator

    Firm Name
    Mallinckrodt Hospital Products Inc.
    Operator Number
    10057439
    Address
    440 Route 22 East, Suite 302
    City
    Bridgewater
    State
    NJ
    Postal Code
    08807
    Country
    US
    Correspondent
    Mark Wendelken

    Products

    Device Name Product Code
    System, Photopheresis, Extracorporeal LNR
    Analyzer, Nitric Oxide MRP
    Apparatus, Nitric Oxide, Backup Delivery MRO
    Apparatus, Nitric Oxide Delivery MRN
    Analyzer, Nitrogen Dioxide MRQ
    Gas, Calibration (Specified Concentration) BXK

    Proprietary Names

    Therakos Cellex Photopheresis System INOmax DSIR Plus MRI (Delivery System) INOcal Nitric Oxide Calibration Gas INOcal Nitrogen Dioxide Calibration Gas Evolve Nitric Oxide Delivery System INOmax DSIR (Delivery System)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198