BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DIRECTMED, INC.

    Reg #: 2437459 · FEI: 3000718659 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    DIRECTMED, INC.
    Registration Number
    2437459
    FEI Number
    3000718659
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    98 PRATT OVAL
    City
    GLEN COVE
    State
    NY
    ZIP
    11542
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150513

    Owner / Operator

    Firm Name
    DIRECTMED, INC.
    Operator Number
    9030198
    Address
    98 PRATT OVAL, --
    City
    Glen Cove
    State
    NY
    Postal Code
    11542
    Country
    US

    Products

    Device Name Product Code
    Catheter, Irrigation GBX
    Set, Administration, Intravascular FPA

    Proprietary Names

    Grace Medical, Inc. OTOMED, Inc. Medical Marketing, Inc. Curaplex Medaxis LLC Fresenius Kabi USA, LLC HMG Distribution LLC DIRECTMED MARIAN MEDICAL

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility