BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Guardian II Hemostasis Valve, Guardian II NC Hemostasis Valve

    Reg #: 3003630504 · FEI: 3002468842 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HARMAC MEDICAL PRODUCTS
    Registration Number
    3003630504
    FEI Number
    3002468842
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    I.D.A. BUSINESS PARK
    City
    CASTLEREA Roscommon
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K122301

    Owner / Operator

    Firm Name
    HARMAC MEDICAL PRODUCTS, INC.
    Operator Number
    1317547
    Address
    2201 BAILEY AVE., --
    City
    Buffalo
    State
    NY
    Postal Code
    14211
    Country
    US
    Correspondent
    Nathan Monin

    US Agent

    Business Name
    Harmac Medical Products
    Contact Name
    Nathan Monin
    Address
    2201 Bailey Ave.
    City
    Buffalo
    State
    NY
    ZIP
    14211
    Country
    US
    Email
    [email protected]
    Phone
    716 8974500 ext. 187

    Products

    Device Name Product Code
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL

    Proprietary Names

    Guardian II Hemostasis Valve, Guardian II NC Hemostasis Valve

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)