BEUDAMED
    FDA Registration Active 🇺🇸 United States

    QFLOW 500TM Perfusion Probe

    Reg #: 3003730855 · FEI: 3003730855 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HEMEDEX INCORPORATED
    Registration Number
    3003730855
    FEI Number
    3003730855
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    564 Main Street, Suite 300
    City
    North Waltham
    State
    MA
    ZIP
    02452
    Country
    US

    Regulatory Submissions

    510(k) Number
    K013376

    Owner / Operator

    Firm Name
    HEMEDEX INCORPORATED
    Operator Number
    9048090
    Address
    564 Main Street, Suite 300
    City
    Waltham
    State
    MA
    Postal Code
    02452
    Country
    US
    Correspondent
    Stefanie - Cantin

    Products

    Device Name Product Code
    Flowmeter, Blood, Cardiovascular DPW

    Proprietary Names

    QFLOW 500TM Perfusion Probe Bowman Perfusion Monitor®

    Establishment Types

    Manufacture Medical Device