BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IACS

    Reg #: 3005783425 · FEI: 3005783425 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    11

    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
    K113798

    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, Breathing Frequency BZQ
    Oximeter DQA
    Continuous Measurement Thermometer FLL
    Monitor, Apnea, Facility Use FLS
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    System, Network And Communication, Physiological Monitors MSX
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Computer, Blood-Pressure DSK
    Monitor, St Segment With Alarm MLD

    Proprietary Names

    IACS Infinity M-Cable Rainbow SET Infinity M-Cable Analog/Sync Infinity M-Pod Quad Hemo Infinity M540 Infinity Acute Care System Masimo Rainbow SET M-Cable Infinity M-Cable Masimo SET Infinity M-Cable Dual Hemo Infinity M-Cable Nellcor OxiMax

    Establishment Types

    Manufacture Medical Device