BEUDAMED
    FDA Registration Active 🇺🇸 United States

    The Swirler Nebulizer

    Reg #: 3034521 · FEI: 3003350319 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INTERNATIONAL ISOTOPES INC.
    Registration Number
    3034521
    FEI Number
    3003350319
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4137 Commerce Cir
    City
    IDAHO FALLS
    State
    ID
    ZIP
    83401
    Country
    US

    Regulatory Submissions

    510(k) Number
    K952910

    Owner / Operator

    Firm Name
    INTERNATIONAL ISOTOPES INC.
    Operator Number
    9045407
    Address
    4137 COMMERCE CIRCLE, --
    City
    Idaho Falls
    State
    ID
    Postal Code
    83401
    Country
    US

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF

    Proprietary Names

    The Swirler Nebulizer The RadVent Swirler Nebulizer Swirler Radvent Swirler

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility