BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Neonatal Flow Sensor ISO15

    Reg #: 3001104093 · FEI: 3023530182 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DRAEGERWERK AG & CO. KGAA
    Registration Number
    3001104093
    FEI Number
    3023530182
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    REVALSTRASSE 1
    City
    LUEBECK Schleswig-Holstein
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K974176

    Owner / Operator

    Firm Name
    Draegerwerk AG & Co. KGaA
    Operator Number
    8010046
    Address
    53-55 MOISLINGER ALLEE, --
    City
    LUEBECK
    State
    DE-NOTA
    Postal Code
    23542
    Country
    DE

    US Agent

    Business Name
    DRAEGER MEDICAL SYSTEMS, INC.
    Contact Name
    John Ferros
    Address
    6 TECH DRIVE
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US
    Email
    [email protected]
    Phone
    978 4095937

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK

    Proprietary Names

    Neonatal Flow Sensor ISO15 Babylog 8000 plus Neonatal Flow Sensor Insert Neonatal flow sensor Y-piece

    Establishment Types

    Manufacture Medical Device