BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Draegerwerk AG & Co. KGaA

    Reg #: 9611500 · FEI: 3001104093 · Expires 2026
    View on FDA
    Products
    55
    Proprietary Names
    143
    Establishment Types
    6
    Classifications
    55

    Registration Details

    Registration Name
    Draegerwerk AG & Co. KGaA
    Registration Number
    9611500
    FEI Number
    3001104093
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    53/55 MOISLINGER ALLEE
    City
    LUEBECK Schleswig-Holstein
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K984577

    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
    Melissa Gray
    Address
    6 TECH DRIVE
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US
    Email
    [email protected]
    Phone
    978 4473613

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK
    Drain, Tee (Water Trap) BYH
    Gas-Machine, Anesthesia BSZ
    Lamp, Surgical FTD
    Mask, Oxygen, Non-Rebreathing KGB
    Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP
    Regulator, Pressure, Gas Cylinder CAN
    Tubing, Noninvasive GAZ
    Filter, Bacterial, Breathing-Circuit CAH
    Mask, Oxygen, Low Concentration, Venturi BYF
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Device, Medical Examination, Ac Powered KZF
    Warmer, Infant Radiant FMT
    Incubator, Neonatal FMZ
    Mask, Gas, Anesthetic BSJ
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Light, Surgical, Accessories FTA
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Unit, Neonatal Phototherapy LBI
    System, Network And Communication, Physiological Monitors MSX
    Humidifier Nebulizer Kit OGG
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Protector, Skin Pressure FMP
    Vaporizer, Anesthesia, Non-Heated CAD
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Oximeter DQA
    Absorbent, Carbon-Dioxide CBL
    Ventilator, Non-Continuous (Respirator) BZD
    Detector And Alarm, Arrhythmia DSI
    Pack, Hot Or Cold, Water Circulating ILO
    Table, Operating-Room, Ac-Powered FQO
    Bottle, Collection, Vacuum KDQ
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Mask, Oxygen BYG
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Cannula, Nasal, Oxygen CAT
    Bag, Reservoir BTC
    Strap, Head, Gas Mask BTK
    Connector, Airway (Extension) BZA
    Absorber, Carbon-Dioxide BSF
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Transducer, Gas Flow BXP
    Cable, Electrode IKD
    Blood Pressure Cuff DXQ
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Continuous Measurement Thermometer FLL

    Proprietary Names

    VentStar Oxylog 2000 WaterLock2 Infinity ID WaterLock2 VentStar Watertrap Fabius MRI Polaris 100/200 O2Star Anesthesia Circuit Kit Basic (P) Anesthesia Circuit Kit Basic Anesthesia Circuit Kit Flex (P) Anesthesia Circuit Kit Coaxial Anesthesia Circuit Kit Flex REGULATOR PRESSURE GAS CYLINDER Hoses and connectors Filter/HME TwinStar Filter SafeStar Filter CareStar Oxylog 3000 and Accessories HME HumidStar Evita V800 Evita V600 T-adapter MX300/M300i 15mm, disposable Expiratory hose extension Dräger Breathing Set T-piece N for NO-A T-piece N for Nebulization IACS WS CriticalCare w V500 VarioLux Babyleo TN500 SediStar Mask LiteStar Mask Double connector 11ID/15OD 20x VentStar humidifier chamber (N) VentStar Helix dual heated N Exten. Kit VentStar Helix heated (N) Plus Atlan A100 XL Atlan A100 Atlan A350 XL Atlan A350 MRI Patient Monitoring System Tesla M3 Disposable Surgical Light Handle Cover Babytherm 8004, 8010 Babylog 8000 Savina INFINITY MONITORS WITH SCIO MODIFICATIONS Photo Therapie 4000 PT 4000 Infinity C700 for IT Caleo Seattle PAP Plus IBP Adapter Cable Draeger 7pin IBP cable Becton Dickinson IBP cable Edwards IBP Adapter Cable Draeger 10pin IBP cable Utah IBP cable Abbott, Medex Positioning Aid Hug-It Positioning Aid Set Positioning Aid Nesting Vapor 3000 Vapor 2000 Inf.ID Breath.CircuitSm. 150 Filter SafeStar Plus Filter/HME TwinStar Plus Filter CareStar Plus Vamos Savina 300 DRAEGER SORB Evita V600 Evita V800 Anesthesia Workstation Perseus A500 Perseus A500 Seattle-PAP Bubble CPAP Skin Temperature Probe, disposable General Purpose Temperature Probe, disposable Infinity MCable CO2 Disposible CO2 cuvette, pead. CO2-Cuvette Paed. CO2-Cuvette ERW Disposible CO2 cuvette, adult BABYTHERM 8000 WB Ambia Column/Head Ambia GeminaDUO Pendula Movita Agila Ponta Forta VacuSmart, VacuSmart Gel, VacuSmart Tube, Receptacle, Secretion jar set, Secretion bottle, Suction accessories VentStar AutoBreath heated (N) VentStar Resus heated (N) Babylog 8000 plus Neonatal Flow Sensor ISO15 Neonatal Flow Sensor Insert Neonatal flow sensor Y-piece VarioVac Polaris 600 Polaris Oxylog 3000 Plus with accessories Oxylog 1000 SmartPilot View D-Vapor D-Vapor 3000 CO2 Mainstream Sensor Apollo Atlan Babylog VN800 Babylog VN600 Babyflow Plus Babyflow HI-Flow Star Adult S HI-Flow Star Adult L HI-Flow Star Adult M VentView VentStar Breathing Bag VentStar MRI (N) 300 Selftestlung Headgear, disposable ErgoStar AC ErgoStar CM CLIC Adapter Carina NovaStar ClassicStar VentStar Heated Infinity ID Breathing Circuit Heated VentStar Resuscitaire Spirolog Flow Sensor SpiroLife Infinity ID Flow Sensor ECG lead, disposable Multi and Monolead ECG lead, reusable Evita 4 NBP extension hose /adapter NBP Cuff for Adult NBP Cuff for Neonates NBP Cuff for Child NBP Cuff for Infant Sample Line Set Dräger Temperature Probes Pediatric Dräger Temperature Probes Adult

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Foreign Private Label Distributor