BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gateway

    Reg #: 3005783425 · FEI: 3005783425 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DRAEGER MEDICAL SYSTEMS, INC.
    Registration Number
    3005783425
    FEI Number
    3005783425
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6 TECH DRIVE
    City
    ANDOVER
    State
    MA
    ZIP
    01810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K043549

    Owner / Operator

    Firm Name
    Draeger Medical Systems, Inc.
    Operator Number
    9070398
    Address
    6 Tech Drive
    City
    Andover
    State
    MA
    Postal Code
    01810
    Country
    US

    Products

    Device Name Product Code
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX

    Proprietary Names

    Gateway Infinity Gateway Suite

    Establishment Types

    Manufacture Medical Device