BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EXCELERON MEDICAL, LLC

    Reg #: 3007709321 · FEI: 3007709321 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    4

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    Registration Details

    Registration Name
    EXCELERON MEDICAL, LLC
    Registration Number
    3007709321
    FEI Number
    3007709321
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    5000 Township Pkwy
    City
    Saint Paul
    State
    MN
    ZIP
    55110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241268

    Owner / Operator

    Firm Name
    Exceleron Medical
    Operator Number
    10038616
    Address
    6 Apple Orchard Court
    City
    Dellwood
    State
    MN
    Postal Code
    55110
    Country
    US
    Correspondent
    Keith Roberts

    Products

    Device Name Product Code
    Filter, Bacterial, Breathing-Circuit CAH
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Ventilator, Non-Continuous (Respirator) BZD
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE

    Proprietary Names

    SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) Thermalite Heated CPAP Tube

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Manufacture Medical Device