BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    BioFlo Duramax

    Reg #: 3033589330 · FEI: 3033589330 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Merit Medical Australia Pty Ltd.
    Registration Number
    3033589330
    FEI Number
    3033589330
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    53 Canterbury Road
    City
    Braiside Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K131260

    Owner / Operator

    Firm Name
    Merit Medical Systems, Inc.
    Operator Number
    1721504
    Address
    1600 West Merit Parkway, --
    City
    South Jordan
    State
    UT
    Postal Code
    84095
    Country
    US

    US Agent

    Business Name
    MERIT MEDICAL SYSTEMS, INC.
    Contact Name
    John Knorpp
    Address
    1600 West Merit Parkway, --
    City
    South Jordan
    State
    UT
    ZIP
    84095
    Country
    US
    Email
    [email protected]
    Phone
    801 2084389

    Products

    Device Name Product Code
    Catheter, Hemodialysis, Implanted MSD

    Proprietary Names

    BioFlo Duramax

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device