BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    AirLife DuoTherm® Temperature Probe, Reusable, 180 cm

    Reg #: 9615827 · FEI: 3003080079 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    WILAMED GMBH
    Registration Number
    9615827
    FEI Number
    3003080079
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Aurachhoehe 5 7
    City
    Kammerstein Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K231380

    Owner / Operator

    Firm Name
    WILAmed GmbH
    Operator Number
    10033146
    Address
    Aurachhoehe 5 7
    City
    Kammerstein
    State
    Bavaria
    Postal Code
    91126
    Country
    DE

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE

    Proprietary Names

    AirLife DuoTherm® Temperature Probe, Reusable, 180 cm AirLife DuoTherm® Temperature Probe, Reusable, 160 cm AirLife DuoTherm® Heated Humidifier, 110-120V AirLife DuoTherm® Reusable Single-Limb Heated Wire Adapter AirLife DuoTherm® Reusable Dual-Limb Heated Wire Adapter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)