BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AEROBIOTIX USA

    Reg #: 3014151865 · FEI: 3014151865 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    AEROBIOTIX USA
    Registration Number
    3014151865
    FEI Number
    3014151865
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    444 Alexandersville Rd
    City
    Miamisburg
    State
    OH
    ZIP
    45342
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203189

    Owner / Operator

    Firm Name
    Aerobiotix USA
    Operator Number
    10094028
    Address
    444 Alexandersville Rd.
    City
    Miamisburg
    State
    OH
    Postal Code
    45342
    Country
    US
    Correspondent
    Michael Schmitz

    Products

    Device Name Product Code
    Drape, Surgical, Exempt PUI
    Purifier, Air, Ultraviolet, Medical FRA
    Apparatus, Air Handling, Room FZH

    Proprietary Names

    AeroCure Vac Sterile Filter Drape AeroCure Vac Filter Drape AeroCure Vac Hose XL AeroCure-HUAIRS AeroCure Vac HEPA Filter Assembly ULPA Carbon F Filter AeroCure Vac Extended Use RFID Cartridge Illuvia HEPA Filter Cartridge Assembly RFID Illuvia SENSE UVC Germicidal Lamp Per-procedure Cartridge Assembly Performance Level 1 Cartridge Assemble Performance Level 2

    Establishment Types

    Manufacture Medical Device