BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Myocardial Temperature Probe

    Reg #: 3004986960 · FEI: 3004986960 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Medisurge
    Registration Number
    3004986960
    FEI Number
    3004986960
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2140 Oak Industrial Dr. NE
    City
    Grand Rapids
    State
    MI
    ZIP
    49505
    Country
    US

    Regulatory Submissions

    510(k) Number
    K020365

    Owner / Operator

    Firm Name
    Medisurge
    Operator Number
    9068542
    Address
    2140 Oak Industrial Dr NE, --
    City
    Grand Rapids
    State
    MI
    Postal Code
    49505
    Country
    US
    Correspondent
    Megan M Morrissey

    Products

    Device Name Product Code
    Accessory Equipment, Cardiopulmonary Bypass KRI

    Proprietary Names

    Myocardial Temperature Probe Myocardial Temperature Probe (15mm)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)