BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BioFlo PICC with ENDEXO Technology-Maximal Barrier Nursing Kit

    Reg #: 1319211 · FEI: 1319211 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ANGIODYNAMICS, INC.
    Registration Number
    1319211
    FEI Number
    1319211
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    603 QUEENSBURY AVE.
    City
    Queensbury
    State
    NY
    ZIP
    12804
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163452

    Owner / Operator

    Firm Name
    ANGIODYNAMICS, INC
    Operator Number
    9028212
    Address
    26 Forest St., --
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    Products

    Device Name Product Code
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Midline Catheter PND

    Proprietary Names

    BioFlo PICC with ENDEXO Technology-Maximal Barrier Nursing Kit BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology-Maximal Barrier Nursing Kit BioFlo PICC with ENDEXO and PASV Valve Technology-Maximal Barrier Nursing Kit Xcela Power Injectable PICC Maximal Barrier Nursing Kit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)