BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Impella 5 Pump (Pump 150)

    Reg #: 2528981 · FEI: 2528981 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Cosmed Group Inc.
    Registration Number
    2528981
    FEI Number
    2528981
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2205 E 33rd St
    City
    ERIE
    State
    PA
    ZIP
    16510
    Country
    US

    Regulatory Submissions

    510(k) Number
    K083111

    Owner / Operator

    Firm Name
    Cosmed Group Inc
    Operator Number
    10053580
    Address
    19 Park Drive
    City
    Franklin
    State
    NJ
    Postal Code
    07416
    Country
    US
    Correspondent
    Christine Render

    Products

    Device Name Product Code
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM

    Proprietary Names

    Impella 5 Pump (Pump 150) European Quick Set-up Kit Quick Set-up Kit Silicone Plugs Accessory for Impella 5 Pump Purge Cassette Axillary Insertion Clamp Kit Incision Template Accessory for Impella LD Impella LD Pump (Pump 100)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)