BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    DirectView Data Management System

    Reg #: 3001400310 · FEI: 3001400310 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Respironics Deutschland GmbH & Co.KG
    Registration Number
    3001400310
    FEI Number
    3001400310
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Gewerbestr. 17
    City
    Herrsching Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K121623

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    2518422
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    US Agent

    Business Name
    Philips
    Contact Name
    Tom Fallon
    Address
    6501 Living Place
    City
    Pittsburgh
    State
    PA
    ZIP
    15206
    Country
    US
    Email
    [email protected]
    Phone
    978 9415572

    Products

    Device Name Product Code
    Ventilator, Continuous, Minimal Ventilatory Support, Facility Use MNT

    Proprietary Names

    DirectView Data Management System Encore Anywhere A40 Heated Humidifier Universal Battery Pack (UBP2) OMNILAB DIRECT BiPAP A40 Ventilatory Support System

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device