Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611500

FEI Number

3001104093

Entity Name

Draegerwerk AG & Co. KGaA

City/State/Country

LUEBECK Schleswig-Holstein, DE

Establishment Address

53/55 MOISLINGER ALLEE, LUEBECK Schleswig-Holstein 23542, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Draegerwerk AG & Co. KGaA (Owner Number: 8010046)

Owner / Operator Contact Address

53-55 MOISLINGER ALLEE, --, LUEBECK, DE-NOTA 23542, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K103035

PMA Number

N/A

All Registered 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 O2Star 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 Dräger Breathing Set 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 Babyleo TN500 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 O2Star VarioVac Polaris 600 Polaris Oxylog 3000 Plus with accessories Oxylog 1000 SmartPilot View

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2022-06-24
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2008-11-26
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2008-08-05
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2013-04-05
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2014-01-09
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2013-09-27
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	1977-12-15
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2022-06-21
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2008-02-04
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2010-06-11
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2014-01-09
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2008-02-07
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2026-05-15
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2006-10-11
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2010-04-13
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2012-06-29
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2026-02-16
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2026-02-16
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	1977-12-15
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2023-06-20
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2026-05-29
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2019-09-13
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2019-09-13
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2017-04-03
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2018-12-18
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2007-12-19
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2007-12-19
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2007-12-19
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2013-02-08
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2007-12-19
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2008-02-07
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	1998-02-04
OGG	Humidifier Nebulizer Kit	Anesthesiology	Class 2	868.5450	2018-12-18
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2025-12-11
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2009-02-06
CAD	Vaporizer, Anesthesia, Non-Heated	Anesthesiology	Class 2	868.5880	2007-12-13
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2007-12-20
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	1977-12-15
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2023-01-05
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2007-12-20
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2007-12-20
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2007-12-20
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2007-12-20
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2007-12-20
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2014-11-04
CBL	Absorbent, Carbon-Dioxide	Anesthesiology	Class 1	868.5300	1998-06-08
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2023-06-01
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2014-06-23
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2021-01-20
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2011-03-07
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2010-04-27
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	1995-05-30
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2012-12-20
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2015-08-12
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2025-05-12
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2025-05-12
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2007-12-19
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2014-01-09
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2004-06-22
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2016-04-22
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2011-10-17
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2011-10-17
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2010-05-17
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2022-06-24

Official Correspondent

No official correspondent registered.

US Agent Details

Melissa Gray Business: DRAEGER MEDICAL SYSTEMS, INC. Email: melissa.gray@draeger.com Phone: (978) 4473613

Related Public Records

Same Entity

Draegerwerk AG & Co. KGaA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3001104093	DRAEGERWERK AG & CO. KGAA	LUEBECK Schleswig-Holstein, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31
K252746	Drägerwerk AG Co. Kgaa	Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)	2026-05-21
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

Similar Registrations

Registration Number	Establishment Name	Location
3029922922	ORIGIN MEDICAL DEVICES HUNGARY KFT	Vac Pest, HU
3012667060	HMC Premedical S.p.A.	Medolla Modena, IT
2024500	COVIDIEN	CARLSBAD, CA, US
3001104093	DRAEGERWERK AG & CO. KGAA	LUEBECK Schleswig-Holstein, DE
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611500. Last updated year: 2026. Please use registration number 9611500 when referencing this establishment in official correspondence.