BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Airvo 2 Series Humidifier

    Reg #: 2085602 · FEI: 3000210616 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FISHER & PAYKEL HEALTHCARE, INC.
    Registration Number
    2085602
    FEI Number
    3000210616
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    17400 Laguna Canyon Road, #300
    City
    IRVINE
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131895

    Owner / Operator

    Firm Name
    FISHER & PAYKEL HEALTHCARE NZ LTD
    Operator Number
    8040217
    Address
    15 MAURICE PAYKEL PLACE
    City
    EAST TAMAKI, AUCKLAND
    State
    NZ-NOTA
    Postal Code
    2013
    Country
    NZ

    Products

    Device Name Product Code
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT

    Proprietary Names

    Airvo 2 Series Humidifier Disinfection kit AUTOFEED CHAMBER WATERBAG AIRVO 2 HUMIDIFIER PT100US myAirvo 2 Humidifier HEATED BREATHING TUBE AND CHAMBER KIT Tube and Chamber Kit (Junior) myAIRVO 2 HUMIDIFIER PT101US Airvo 2 Humidifier Chamber Reusable for HC600 Series HEATED BREATHING TUBE

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198