BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DRAEGER MEDICAL SYSTEMS, INC.

    Reg #: 3005783425 · FEI: 3005783425 · Expires 2026
    View on FDA
    Products
    41
    Proprietary Names
    81
    Establishment Types
    3
    Classifications
    41

    Registration Details

    Registration Name
    DRAEGER MEDICAL SYSTEMS, INC.
    Registration Number
    3005783425
    FEI Number
    3005783425
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6 TECH DRIVE
    City
    ANDOVER
    State
    MA
    ZIP
    01810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K991884

    Owner / Operator

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

    Products

    Device Name Product Code
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    System, Network And Communication, Physiological Monitors MSX
    Stimulator, Nerve, Peripheral, Electric KOI
    Oximeter DQA
    Ventilator, Continuous, Facility Use CBK
    Monitor, St Segment With Alarm MLD
    Monitor, Apnea, Facility Use FLS
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Burst Suppression Detection Software For Electroencephalograph ORT
    Monitor, Breathing Frequency BZQ
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Computer, Blood-Pressure DSK
    Plethysmograph, Impedance DSB
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Catheter, Oximeter, Fiber-Optic DQE
    Recorder, Paper Chart DSF
    Electrocardiograph DPS
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Gas-Machine, Anesthesia BSZ
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Reduced- Montage Standard Electroencephalograph OMC
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Continuous Measurement Thermometer FLL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Index-Generating Electroencephalograph Software OLW
    Stimulator, Muscle, Powered IPF
    Detector And Alarm, Arrhythmia DSI
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Connector, Airway (Extension) BZA
    Spirometer, Monitoring (W/Wo Alarm) BZK
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
    Electrode, Electrocardiograph DRX
    Transducer, Gas Flow BXP
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Cannula, Nasal, Oxygen CAT

    Proprietary Names

    FI02 Sensor Cable Gateway Infinity Gateway Suite Infinity Trident NMT Pod Infinity Trident Pod System Infinity Acute Care System (IACS) Monitoring System Y-Adapter PS120 Desktop Power Supply Infinity Acute Care System (IACS) Monitoring Solution - C500 Cockpit Infinity Acute Care System (IACS) Monitoring Solution - M540 P2500 Power Supply Infinity Acute Care System (IACS) Monitoring Solution - C700 Cockpit Infinity Acute Care System (IACS) Monitoring Solution - M500 Docking Station Infinity M-Cable Masimo Rainbow Set etCO2 Airway Adaptor - Sidestream etCO2 Airway Adaptor-Neonatal etCO2 Airway Adaptor - Adult Infinity Symphony Suite Symphony Infinity CentralStation Wide Infinity CentralStation Infinity Gamma XL Infinity Gamma Infinity Vista Infinity Masimo SpO2 SmartPod SpO2 MasimoSet Pod Set Kit SpO2 Masimo Pod Infinity etCO2 SmartPod etCO2 Pod Kit Infinity etCO2 Module CNAP Accessories Infinity CNAP SmartPod Infinity Docking Station MIB II MIB II Protocol Converter Infinity Kappa XLT etCO2 Respiratory Mech SmartPod Infinity tpO2 / tpCO2 Smart Pod INFINITY OMEGA S SOLUTION INFINITY EXPLORER INFINITY OMEGA MONITOR INFINITY EXPLORER MONITOR INFINITY OMEGA SOLUTION Infinity CentralStation Infinity 300 Infinity M-Cable Rainbow SET Infinity Acute Care System IACS Masimo Rainbow SET M-Cable Infinity M-Cable Analog/Sync Infinity M-Pod Quad Hemo Infinity M-Cable Masimo SET Infinity M-Cable Dual Hemo Infinity M-Cable Nellcor OxiMax Infinity M540 NeoMed Pod Infinity Hemo 4 Pod Infinity Vista XL Infinity BisX Pod MultiMed Pod MultiMed Plus OR Infinity HemoMed MultiMed Plus Infinity Gamma XXL Infinity Hemo 2 Pod Infinity Nellcor OxiMax SmartPod INFINITY DELTA, DELTA XL & KAPPA MONITORS WITH INFINITY MCABLE MAINSTREAM CO2 ECG Electrodes, Disposable R50 Universal Recorder R50N Recorder Infinity R50-S Recorder Infinity CentralStation Wide, Infinity M300, Infinity M300+ Respiratory Mechanics Combined Flow/CO2 Sensor – Adult/pediatric Respiratory Mechanics Combined Flow/CO2 Sensor – Pediatric Respiratory Mechanics Sensor – Neonatal Respiratory Mechanics Combined Flow/CO2 Sensor – Neonatal Respiratory Mechanics Flow Sensor – Adult/Pediatric Infinity PICCO SmartPod EEG Infinity Pod etCO2 Nafion Tubing etCO2 S-Cannula - Adult etCO2 S-Cannula - Pediatric

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198