Draegerwerk Ag Co Kgaa

FDA Filings

This page includes the latest FDA filings for Draegerwerk Ag Co Kgaa. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9611500
FEI Number3001104093
NameGale Winarsky
Owner & OperatorDraegerwerk AG & Co. KGaA
Contact Address53-55 MOISLINGER ALLEE --
LUEBECK DE-NOTA 23542 DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3135 Quarry Rd.
Telford, PA 18969 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Complaint File Establishment per 21 CFR 820.198
  • Foreign Private Label Distributor



Registration Number3001104093
FEI Number3001104093
NameDRAEGERWERK AG & CO. KGAA
Owner & OperatorDraegerwerk AG & Co. KGaA
Contact Address53-55 MOISLINGER ALLEE --
LUEBECK DE-NOTA 23542 DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressREVALSTRASSE 1
LUEBECK Schleswig-Holstein, 23560 DE
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Babyleo TN5002019-09-13
DRAEGERWERK AG & CO. KGAA
Babyleo TN5002019-09-13
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Babyleo TN5002019-09-13
DRAEGERWERK AG & CO. KGAA
Babyleo TN5002019-09-13
DRAEGERWERK AG & CO. KGAA
Savina 300 - Classic, Select2019-02-13
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Seattle PAP Plus2018-12-18
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Disposable Surgical Light Handle Cover2018-12-18
DRAEGERWERK AG & CO. KGAA
Babyleo TN5002017-06-27
DRAEGERWERK AG & CO. KGAA
Babyleo TN5002017-06-27
Draegerwerk AG & Co. KGaA
Babyleo TN5002017-06-23
Gale Winarsky [Draegerwerk AG & Co. KGaA]
MRI Patient Monitoring System Tesla M32017-04-03
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Polaris 6002016-04-22
DRAEGERWERK AG & CO. KGAA
Polaris 6002016-04-22
Gale Winarsky [Draegerwerk AG & Co. KGaA]
VacuSmart, VacuSmart Gel, VacuSmart Tube2015-08-12
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Savina 3002014-11-04
DRAEGERWERK AG & CO. KGAA
Savina 3002014-11-04
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Perseus A5002014-06-23
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Anesthesia Workstation Perseus A5002014-06-23
DRAEGERWERK AG & CO. KGAA
Perseus A5002014-06-23
DRAEGERWERK AG & CO. KGAA
Anesthesia Workstation Perseus A5002014-06-23
Gale Winarsky [Draegerwerk AG & Co. KGaA]
O2Star2014-01-09
Gale Winarsky [Draegerwerk AG & Co. KGaA]
O2Star2014-01-09
Gale Winarsky [Draegerwerk AG & Co. KGaA]
O2Star2014-01-09
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Anesthesia Circuit Kit Flex2013-09-27
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Anesthesia Circuit Kit Flex (P)2013-09-27
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Anesthesia Circuit Kit Coaxial2013-09-27
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Anesthesia Circuit Kit Basic2013-09-27
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Anesthesia Circuit Kit Basic (P)2013-09-27
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Dr?ger Temperature Probes Pediatric2013-05-17
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Dr?ger Temperature Probes Adult2013-05-17
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Polaris 100/2002013-04-05
DRAEGERWERK AG & CO. KGAA
Polaris 100/2002013-04-05
Gale Winarsky [Draegerwerk AG & Co. KGaA]
INFINITY MONITORS WITH SCIO MODIFICATIONS2013-02-08
DRAEGERWERK AG & CO. KGAA
INFINITY MONITORS WITH SCIO MODIFICATIONS2013-02-08
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Ponta2012-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Pendula2012-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Movita2012-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
GeminaDUO2012-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Forta2012-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Agila2012-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
VarioLux2012-06-29
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Oxylog 3000 Plus with accessories2011-10-17
DRAEGERWERK AG & CO. KGAA
Oxylog 3000 Plus with accessories2011-10-17
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Oxylog 3000 Plus with accessories2011-10-17
DRAEGERWERK AG & CO. KGAA
Oxylog 3000 Plus with accessories2011-10-17
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Skin Temperature Probe, disposable2011-03-07
Gale Winarsky [Draegerwerk AG & Co. KGaA]
General Purpose Temperature Probe, disposable2011-03-07
Gale Winarsky [Draegerwerk AG & Co. KGaA]
VentStar Heated2011-01-06
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Infinity ID Breathing Circuit Heated2011-01-06
Gale Winarsky [Draegerwerk AG & Co. KGaA]
ECG lead, reusable2010-10-27
Gale Winarsky [Draegerwerk AG & Co. KGaA]
ECG lead, disposable2010-10-27
Gale Winarsky [Draegerwerk AG & Co. KGaA]
VentStar Resuscitaire2010-08-18
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Oxylog 2000 Plus and Accessories2010-06-11
DRAEGERWERK AG & CO. KGAA
Oxylog 2000 Plus and Accessories2010-06-11
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Oxylog 3000 and Accessories2010-06-11
DRAEGERWERK AG & CO. KGAA
Oxylog 3000 and Accessories2010-06-11
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Oxylog 10002010-05-17
DRAEGERWERK AG & CO. KGAA
Oxylog 10002010-05-17
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Infinity MCable CO22010-04-27
Gale Winarsky [Draegerwerk AG & Co. KGaA]
IACS WS CriticalCare w V5002010-04-13
DRAEGERWERK AG & CO. KGAA
IACS WS CriticalCare w V5002010-04-13
Gale Winarsky [Draegerwerk AG & Co. KGaA]
IACS WS NeonatalCare w VN5002010-04-13
DRAEGERWERK AG & CO. KGAA
IACS WS NeonatalCare w VN5002010-04-13
Gale Winarsky [Draegerwerk AG & Co. KGaA]
NBP extension hose /adapter2009-11-26
Gale Winarsky [Draegerwerk AG & Co. KGaA]
NBP Cuff for Neonates2009-11-26
Gale Winarsky [Draegerwerk AG & Co. KGaA]
NBP Cuff for Infant2009-11-26
Gale Winarsky [Draegerwerk AG & Co. KGaA]
NBP Cuff for Child2009-11-26
Gale Winarsky [Draegerwerk AG & Co. KGaA]
NBP Cuff for Adult2009-11-26
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Positioning Aid Set2009-02-06
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Positioning Aid Nesting2009-02-06
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Positioning Aid Hug-It2009-02-06
Gale Winarsky [Draegerwerk AG & Co. KGaA]
ErgoStar CM2009-01-29
Gale Winarsky [Draegerwerk AG & Co. KGaA]
ErgoStar AC2009-01-29
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Evita XL2009-01-06
DRAEGERWERK AG & CO. KGAA
Evita XL2009-01-06
Gale Winarsky [Draegerwerk AG & Co. KGaA]
4th Gas Module w. CO2 for Primus US2008-12-16
Gale Winarsky [Draegerwerk AG & Co. KGaA]
WaterLock22008-11-26
Gale Winarsky [Draegerwerk AG & Co. KGaA]
VentStar Watertrap2008-11-26
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Infinity ID WaterLock22008-11-26
Gale Winarsky [Draegerwerk AG & Co. KGaA]
NovaStar2008-10-08
Gale Winarsky [Draegerwerk AG & Co. KGaA]
ClassicStar2008-10-08
DRAEGERWERK AG & CO. KGAA
NovaStar2008-10-08
DRAEGERWERK AG & CO. KGAA
ClassicStar2008-10-08
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Fabius MRI2008-08-05
DRAEGERWERK AG & CO. KGAA
Fabius MRI2008-08-05
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Carina2008-04-16
DRAEGERWERK AG & CO. KGAA
Carina2008-04-16
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Infinity C700 for IT2008-02-07
DRAEGERWERK AG & CO. KGAA
Infinity C700 for IT2008-02-07
Gale Winarsky [Draegerwerk AG & Co. KGaA]
HumidStar Trach Plus2008-02-07
Gale Winarsky [Draegerwerk AG & Co. KGaA]
HME Humidstar2008-02-07
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Filter/HME TwinStar2008-02-04
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Filter SafeStar2008-02-04
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Filter CareStar2008-02-04
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vapor 192007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vapor 192007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vapor 192007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
VentView2007-12-20
DRAEGERWERK AG & CO. KGAA
VentView2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vapor 192007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vapor 192007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Fabius Tiro and accessories2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Fabius GS and accessories2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Fabius GS Premium and accessories2007-12-20
DRAEGERWERK AG & CO. KGAA
Fabius Tiro and accessories2007-12-20
DRAEGERWERK AG & CO. KGAA
Fabius GS and accessories2007-12-20
DRAEGERWERK AG & CO. KGAA
Fabius GS Premium and accessories2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
D-Vapor2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
D-Vapor 30002007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Apnea Ventilation Option for Fabius GS, Fabius Tiro2007-12-20
DRAEGERWERK AG & CO. KGAA
Apnea Ventilation Option for Fabius GS, Fabius Tiro2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
EGM - Essential Gas Module2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Heated Breathing System Option Fabius GS, Fabius Tiro2007-12-20
DRAEGERWERK AG & CO. KGAA
Heated Breathing System Option Fabius GS, Fabius Tiro2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vamos2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vamos2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vamos2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vamos2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vamos2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vamos2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vamos2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vamos2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
PSV Option for Fabius GS2007-12-20
DRAEGERWERK AG & CO. KGAA
PSV Option for Fabius GS2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
VentView2007-12-20
DRAEGERWERK AG & CO. KGAA
VentView2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vamos2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vamos2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vamos2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vamos2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vamos2007-12-20
Gale Winarsky [Draegerwerk AG & Co. KGaA]
ATC Option for Evita2007-12-19
DRAEGERWERK AG & CO. KGAA
ATC Option for Evita2007-12-19
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Neoflow Option for Evita2007-12-19
DRAEGERWERK AG & CO. KGAA
Neoflow Option for Evita2007-12-19
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Dr?ger Medical Air Compressor2007-12-19
DRAEGERWERK AG & CO. KGAA
Dr?ger Medical Air Compressor2007-12-19
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Evita 42007-12-19
DRAEGERWERK AG & CO. KGAA
Evita 42007-12-19
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Babylog 8000 plus2007-12-19
DRAEGERWERK AG & CO. KGAA
Babylog 8000 plus2007-12-19
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Babytherm 8004, 80102007-12-19
DRAEGERWERK AG & CO. KGAA
Babytherm 8004, 80102007-12-19
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Evita 42007-12-19
DRAEGERWERK AG & CO. KGAA
Evita 42007-12-19
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Photo Therapie 40002007-12-19
Gale Winarsky [Draegerwerk AG & Co. KGaA]
PT 40002007-12-19
DRAEGERWERK AG & CO. KGAA
Photo Therapie 40002007-12-19
DRAEGERWERK AG & CO. KGAA
PT 40002007-12-19
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Babylog 80002007-12-19
DRAEGERWERK AG & CO. KGAA
Babylog 80002007-12-19
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Babylog 80002007-12-19
DRAEGERWERK AG & CO. KGAA
Babylog 80002007-12-19
Gale Winarsky [Draegerwerk AG & Co. KGaA]
SmartCare PS Option for Evita XL2007-12-19
DRAEGERWERK AG & CO. KGAA
SmartCare PS Option for Evita XL2007-12-19
Gale Winarsky [Draegerwerk AG & Co. KGaA]
LPO Option for Savina2007-12-19
DRAEGERWERK AG & CO. KGAA
LPO Option for Savina2007-12-19
Gale Winarsky [Draegerwerk AG & Co. KGaA]
NIV Option for Savina2007-12-19
DRAEGERWERK AG & CO. KGAA
NIV Option for Savina2007-12-19
Gale Winarsky [Draegerwerk AG & Co. KGaA]
NIV Option for Evita2007-12-19
DRAEGERWERK AG & CO. KGAA
NIV Option for Evita2007-12-19
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Savina2007-12-19
DRAEGERWERK AG & CO. KGAA
Savina2007-12-19
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vapor 30002007-12-13
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Vapor 20002007-12-13
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Evita 2 dura2007-12-13
DRAEGERWERK AG & CO. KGAA
Evita 2 dura2007-12-13
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Sola2007-12-13
DRAEGERWERK AG & CO. KGAA
Sola2007-12-13
Gale Winarsky [Draegerwerk AG & Co. KGaA]
T-adapter MX300/M300i 15mm, disposable2006-10-11
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Expiratory hose extension2006-10-11
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Dr?ger Breathing Set2006-10-11
Gale Winarsky [Draegerwerk AG & Co. KGaA]
VarioVac2004-06-22
DRAEGERWERK AG & CO. KGAA
VarioVac2004-06-22
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Babyflow2003-11-21
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Babyflow Plus2003-11-21
Gale Winarsky [Draegerwerk AG & Co. KGaA]
DRAGER SORB1998-06-08
DRAEGERWERK AG & CO. KGAA
DRAGER SORB1998-06-08
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Caleo1998-02-04
DRAEGERWERK AG & CO. KGAA
Caleo1998-02-04
Gale Winarsky [Draegerwerk AG & Co. KGaA]
BABYTHERM 8000 WB1995-05-30
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Apollo1986-10-28
DRAEGERWERK AG & CO. KGAA
Apollo1986-10-28
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Fabius Tiro1986-10-28
DRAEGERWERK AG & CO. KGAA
Fabius Tiro1986-10-28
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Fabius GS1986-10-28
DRAEGERWERK AG & CO. KGAA
Fabius GS1986-10-28
Gale Winarsky [Draegerwerk AG & Co. KGaA]
REGULATOR1977-12-15
Gale Winarsky [Draegerwerk AG & Co. KGaA]
PRESSURE1977-12-15
Gale Winarsky [Draegerwerk AG & Co. KGaA]
GAS CYLINDER1977-12-15
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Dr?ger Breathing Set1977-12-15
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Headgear, disposable1977-12-15
Gale Winarsky [Draegerwerk AG & Co. KGaA]
VentStar Breathing Bag1977-12-15
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Dr?ger Breathing Set1977-12-15
Gale Winarsky [Draegerwerk AG & Co. KGaA]
Dr?ger Breathing Set1977-12-15

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092948052Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseySPARE PARTS FOR MEDICAL EQUIPMENT INVOICE 16530966, 16530976 HS-CODE 854442, 732690 HBL BANQBRE4451705 .7 PKG
2020092948055Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT INVOICE 16531246 HS-CODE 940540, 731819, 761090, 392590, 730890, 853690, 850440, 391990, 853710, 940592 HBL BANQBRE44554937 PKG
202009261329Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseySPARE PARTS FOR MEDICAL EQUIPMENT HS-CODE 854442 INVOICE 16527736 HBL BANQBRE4350859 . .3 PKG
2020092664661Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaSPARE PARTS FOR MEDICAL EQUIPMENT HS CODE 8421392524 PKG
20200925817Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseySPARE PARTS FOR MEDICAL EQUIPMENT HS-CODE 854442 INVOICE 16527736 HBL BANQBRE4350859 . .3 PKG
2020092520932Stadersand,Federal Republic of Germany -> Charleston, South CarolinaSPARE PARTS FOR MEDICAL EQUIPMENT HS CODE 90192000,39174000 84213925,84811005,84818059213 PKG
2020092520932Stadersand,Federal Republic of Germany -> Charleston, South CarolinaSPARE PARTS FOR MEDICAL EQUIPMENT HS CODE 85076000,85072080 85065010,40169997,85075000 85176200,90269000,84813099213 PKG
2020092453633Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaSPARE PARTS FOR MEDICAL EQUIPMENT HS CODE 8421392524 PKG
2020092430117Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseySPARE PARTS FOR MEDICAL EQUIPMENT INVOICE 16529893 HS-CODE 741220 HBL BANQBRE4440987 . .1 PKG

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