BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Q-Flex, Q2

    Reg #: 1000324175 · FEI: 1000324175 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Halkey-Roberts Corporation
    Registration Number
    1000324175
    FEI Number
    1000324175
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2700 Halkey-Roberts Place North
    City
    Saint Petersburg
    State
    FL
    ZIP
    33716
    Country
    US

    Regulatory Submissions

    510(k) Number
    K002689

    Owner / Operator

    Firm Name
    ATRION CORP.
    Operator Number
    9914015
    Address
    ONE ALLENTOWN PKWY., --
    City
    Allen
    State
    TX
    Postal Code
    75002
    Country
    US

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA

    Proprietary Names

    Q-Flex, Q2 Robersite (Registered) Needlefree Injection Site Valve

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)