Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001104093

FEI Number

3023530182

Entity Name

DRAEGERWERK AG & CO. KGAA

City/State/Country

LUEBECK Schleswig-Holstein, DE

Establishment Address

REVALSTRASSE 1, LUEBECK Schleswig-Holstein 23560, DE

Establishment Type(s)

Manufacture Medical Device

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

N/A

PMA Number

N/A

All Registered Proprietary Names

NovaStar ClassicStar Evita V800 Evita V600 Babylog 8000 Anesthesia Workstation Perseus A500 Perseus A500 Atlan Apollo Oxylog 1000 Babylog VN800 Babylog VN600 Babyleo TN500 VarioVac Oxylog 3000 and Accessories Photo Therapie 4000 PT 4000 Carina Fabius MRI VentView Filter SafeStar Plus Filter/HME TwinStar Plus Filter CareStar Plus Polaris 600 Polaris Atlan A100 XL Atlan A100 Atlan A350 XL Atlan A350 Polaris 100/200 Oxylog 3000 Plus with accessories Evita V600 Evita V800 Babyleo TN500 Babylog 8000 plus Neonatal Flow Sensor ISO15 Neonatal Flow Sensor Insert Neonatal flow sensor Y-piece IBP transducer adapter cable, Codan/DPT, 0.3m IBP transducer adapter cable, Draeger 7-pin, 0.3m IBP transducer adapter cable, Argon/BD/Ohmeda, 2m IBP transducer adapter cable, Baxter/Edwards, 2m IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m IBP transducer adapter cable, Baxter/Edwards, 0.3m IBP transducer adapter cable, Draeger 7-pin, 2m IBP transducer adapter cable, Draeger 10-pin, 0.3m IBP transducer adapter cable, Utah Medical, 2m IBP transducer adapter cable, Draeger 10-pin, 2m IBP transducer adapter cable, Utah Medical, 0.3m IBP transducer adapter cable, Codan/Xtrans, 0.3m IBP transd. adapter cable, Abbott/Medex, Smiths/TranStar, 0.3m IBP transducer adapter cable, Codan/DPT, 2m IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m Savina Spirolog Flow Sensor SpiroLife Infinity ID Flow Sensor IACS WS CriticalCare w V500 HME HumidStar Connectivity Converter CC300

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	2008-10-08
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2026-05-15
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2007-12-19
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2014-06-23
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2023-07-25
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	1986-10-28
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2010-05-17
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2023-06-01
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
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2004-06-22
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2010-06-11
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2007-12-19
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2008-04-16
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2008-08-05
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2007-12-20
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2023-01-05
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2016-04-22
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2026-05-29
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2013-04-05
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	2023-06-01
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2017-06-27
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2017-06-27
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2007-12-19
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2026-02-04
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2007-12-19
BXP	Transducer, Gas Flow	Anesthesiology	Class 1	868.2885	2022-03-30
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2010-04-13
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2008-02-07
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2026-03-19

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
9611500	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
K943360	Ohmeda Medical	OHIO CARE PLUS INCUBATOR	1994-09-29
K020219	Replacement Parts Industries, Inc.	RPI SKIN OR AIR TEMPERATURE PROBE	2002-04-12

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

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3012667060	HMC Premedical S.p.A.	Medolla Modena, IT
2024500	COVIDIEN	CARLSBAD, CA, US
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ
9611500	Draegerwerk AG & Co. KGaA	LUEBECK Schleswig-Holstein, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001104093. Last updated year: 2026. Please use registration number 3001104093 when referencing this establishment in official correspondence.