BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Nefes CPAP Nasal Pillow Mask

    Reg #: 3011582224 · FEI: 3011582224 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Genadyne Biotechnologies, Inc.
    Registration Number
    3011582224
    FEI Number
    3011582224
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    519 Johnson Ave
    City
    Bohemia
    State
    NY
    ZIP
    11716
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120920

    Owner / Operator

    Firm Name
    GENADYNE BIOTECHNOLOGIES, INC.
    Operator Number
    9006819
    Address
    16 MIDLAND AVENUE, --
    City
    Hicksville
    State
    NY
    Postal Code
    11801
    Country
    US

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    Nefes CPAP Nasal Pillow Mask

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility