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Draeger Interservices GmbH: FDA-registered device maker in Luebeck Schleswig-Holstein, Germany, 1 510(k) clearance

Draeger Interservices GmbH is registered with the FDA (registration 3049808762) in Luebeck Schleswig-Holstein, Germany. It lists 45 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 13, 2014. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
3049808762
Address
Langensahl 18a, Luebeck Schleswig-Holstein, Germany, 23560
Owner or operator
Draegerwerk AG & Co. KGaA (8010046)
Roles
Contract manufacturer, Repackager or relabeler
First device listed
December 15, 1977
Registered through
2027
Brand names listed
90 -LUERLOCK FOR NEONATES, ADAPTER FOR THERMOMETER, Adapter , Box10, Adapter 9/16" to 6mm, Adapter NBP, Ambia, Anesthesia ID, Anesthesia Set and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorbent, Carbon-DioxideCBL1Contract manufactureraccessdata.fda.gov
Absorber, Carbon-DioxideBSF1Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)NHO2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)CBQ2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)CBS2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)NHQ2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)CBR2Contract manufactureraccessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)NHP2Contract manufactureraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Contract manufactureraccessdata.fda.gov
Attachment, Breathing, Positive End Expiratory PressureBYE2Contract manufactureraccessdata.fda.gov
Bag, ReservoirBTC1Repackager or relabeleraccessdata.fda.gov
Bilirubin (Total And Unbound) In The Neonate Test SystemMQM1Repackager or relabeleraccessdata.fda.gov
Blood Pressure CuffDXQ2Contract manufactureraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Contract manufactureraccessdata.fda.gov
Cable, ElectrodeIKD2Contract manufactureraccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Contract manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Contract manufactureraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Contract manufactureraccessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)BYD1Contract manufactureraccessdata.fda.gov
Connector, Airway (Extension)BZA1Repackager or relabeleraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Contract manufactureraccessdata.fda.gov
Device, Medical Examination, Ac PoweredKZF1Contract manufactureraccessdata.fda.gov
Drain, Tee (Water Trap)BYH1Repackager or relabeleraccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Contract manufactureraccessdata.fda.gov
Gas-Machine, AnesthesiaBSZ2Contract manufactureraccessdata.fda.gov
Heater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerBZE2Contract manufactureraccessdata.fda.gov
Incubator, NeonatalFMZ2Contract manufactureraccessdata.fda.gov
Lamp, SurgicalFTD2Contract manufactureraccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Contract manufactureraccessdata.fda.gov
Medical Device Data SystemOUG1Contract manufactureraccessdata.fda.gov
OximeterDQA2Contract manufactureraccessdata.fda.gov
Protector, Skin PressureFMP1Contract manufactureraccessdata.fda.gov
Regulator, Pressure, Gas CylinderCAN1Contract manufactureraccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Repackager or relabeleraccessdata.fda.gov
Support, Breathing TubeJAY1Contract manufactureraccessdata.fda.gov
System, Network And Communication, Physiological MonitorsMSX2Contract manufactureraccessdata.fda.gov
Table, Operating-Room, Ac-PoweredFQO1Contract manufactureraccessdata.fda.gov
Transducer, Gas FlowBXP1Contract manufactureraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Contract manufactureraccessdata.fda.gov
Vaporizer, Anesthesia, Non-HeatedCAD2Contract manufactureraccessdata.fda.gov
Ventilator, Continuous, Facility UseCBK2Contract manufactureraccessdata.fda.gov
Ventilator, Emergency, Powered (Resuscitator)BTL2Contract manufactureraccessdata.fda.gov
Ventilator, Non-Continuous (Respirator)BZD2Contract manufactureraccessdata.fda.gov
Warmer, Infant RadiantFMT2Contract manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 13, 2014K133175DRAEGER JAUNDICE METER JM-105MQMSubstantially EquivalentDraeger Medical Systems, Inc.accessdata.fda.gov

Compare with other makers

Updated November 13, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.