BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    N95 Respirator, Cone Style

    Reg #: 3014101050 · FEI: 3014101050 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Medline Australia
    Registration Number
    3014101050
    FEI Number
    3014101050
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Fairview Place
    City
    Marsden Park New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K020474

    Owner / Operator

    Firm Name
    Medline Industries, LP
    Operator Number
    1417592
    Address
    Three Lakes Drive
    City
    Northfield
    State
    IL
    Postal Code
    60093
    Country
    US
    Correspondent
    Stephanie Augsburg

    US Agent

    Business Name
    Simcon International LLC
    Contact Name
    Rosanna Lee
    Address
    1200 Townline Rd
    City
    Mundelein
    State
    IL
    ZIP
    60060
    Country
    US
    Email
    [email protected]
    Phone
    847 9492290

    Products

    Device Name Product Code
    Respirator, Surgical MSH

    Proprietary Names

    N95 Respirator, Cone Style

    Establishment Types

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