BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MCH-1000(u)

    Reg #: 3007899424 · FEI: 3007899424 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CardioQuip
    Registration Number
    3007899424
    FEI Number
    3007899424
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8422 Calibration Ct
    City
    College Station
    State
    TX
    ZIP
    77845
    Country
    US

    Regulatory Submissions

    510(k) Number
    K102147

    Owner / Operator

    Firm Name
    CardioQuip LLC
    Operator Number
    10044068
    Address
    8422 Calibration Ct
    City
    College Station
    State
    TX
    Postal Code
    77845
    Country
    US

    Products

    Device Name Product Code
    Controller, Temperature, Cardiopulmonary Bypass DWC

    Proprietary Names

    MCH-1000(u) MCH-1000(m) MCH-1000(i) Modular Cooler-Heater MCH-1000 MCH Micro MCH Mini

    Establishment Types

    Manufacture Medical Device