BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Detachable Vial Connector

    Reg #: 3004201393 · FEI: 3004201393 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    3BY LTD.
    Registration Number
    3004201393
    FEI Number
    3004201393
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BUILDING 14, Industrial Park
    City
    TEFEN Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K001293

    Owner / Operator

    Firm Name
    3BY Ltd.
    Operator Number
    9050049
    Address
    Building 14, Industrial Park, PO Box 65
    City
    Tefen
    State
    Northern
    Postal Code
    2495900
    Country
    IL

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Set, I.V. Fluid Transfer LHI

    Proprietary Names

    Detachable Vial Connector Modification to MIXject dispensing Detachable holder Vial holder Mixject Dispensing pin with Preattached Vial Adapter Needle MixJect

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)