Post on 23-Jan-2021
Dräger
c c8EC Declaration of Conformity Date / DatumEG Konformitätserklärung 2017-07-05
V. V.5 European Directive 93/42/EEC, Annex IIEuropäische Richtlinie 93/42/EWG, Anhang II
Document ID / Dokument Nr.MD108-037-1707-176-0
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23542 Lübeck Germany
hereby declares that the / erklärt hiermit, dass
Product Name / Produktbezeichnung
Medical Device / Medizinprodukt Device Class UMDNS Code/ GMDN Code
02-Aerosol Therapy /02-Aerosol Therapie
Flowmeter, Gas II a 11-748/61365
meets the provisions of the European Directive 93/42/EEC on medical devices. An examination of the quality management System has been carried out following Annex 11.3 of the directive by the Notified Body TÜV Süd Product Service GmbH, Ridlerstraße 65, 80339 Munich, Germany, EC No. 0123. The quality management System also complies to EN ISO 9001 and EN ISO 13485.This declaration is effective for products placed on the market as of the date of issue. Any modifications of the medical device not authorized by Dräger will invalidate this declaration.
mit den Bestimmungen der europäischen Richtlinie 93/42/EWG (Medizinprodukte) übereinstimmt. Eine Überprüfung des Qualitätsmanagementsystems, nach den Regeln wie in Anhang II.3 der Richtlinie beschrieben, wurde durch die Benannte Stelle TÜV Süd Product Service GmbH, Ridlerstraße 65, 80339 München, EU Kennnummer 0123, vorgenommen. Das Qualitätsmanagementsystem erfüllt weiterhin die Anforderungen gemäß EN ISO 9001 und EN ISO 13485.Diese Erklärung ist gültig für ab dem Ausstellungsdatum in Verkehr gebrachte Produkte. Jede nicht durch Dräger autorisierte Modifikation an dem Medizinprodukt führt zur Ungültigkeit dieser Erklärung.
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23558 Lübeck, Germany Postal address:23542 Lübeck, Germany Tel +49 451 882-0 Fax +49 451 882-2080 info@draeger.com www.draeger.com
Bank details:Commerzbank AG, LübeckIBAN DE33 2304 0022 0014 6779 00BIC COBADEFF230Deutsche Bank AG, LübeckIBAN DE85 2307 0710 0031 0003 00BIC DEUTDEHH222
Registered Office: Lübeck Commercial register:Local court Lübeck HRB 7903 HL General partner: Drägerwerk Verwaltungs AG Registered Office: Lübeck Commercial register:Local court Lübeck HRB 7395 HL
Chairman of the Supervisory Board for Drägerwerk AG & Co. KGaA and Drägerwerk Verwaltungs AG:Prof. Dr. Nikolaus Schweickart Executive Board:Stefan Dräger (chairman)Dr. Herbert Fehrecke Gert-Hartwig Lescow Anton Schrofner
Dräger
r C s Appendix to EC Declaration of Conformity Date / DatumAnlage zur EG Konformitätserklärung 2017-07-05U 5 European Directive 93/42/EECEuropäische Richtlinie 93/42/EWG
Document ID / Dokument Nr.MD108-037-1707-176-0-00
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23542 Lübeck Germany
Product name / Produktbezeichnung Medical device / Medizinprodukt
02- Aerosol Therapy / 02-Aerosol Therapie Flowmeter, Gas
Applied Standards in full or in part / Vollständig oder teilweise angewendete Normen:
EN ISO 14971:2012
(ISO 14971:2007 + Cor:2007)
Medical devices - Application of risk management to medical devices
EN ISO 15001:2011
(ISO 15002:2010)
Anaesthetic and respiratory equipment- Compatibility with oxygen
EN ISO 15002:2008
(ISO 15002:2008)
Flow-metering devices for connection to terminal units of medical gas pipeline Systems
EN ISO 10993-1:2009 AC2010
(ISO 10993-1:2009 COR2010)
Biological evaluation of medical devices - Part 1: Evaluation and testing
EN 62366:2008
(IEC 62366:2007)
Medical devices - Application of usabiiity engineering to medical devices
EN ISO 10524-1:2006
(ISO 10524-1:2006)
Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices
EN ISO 8185:2009
(ISO 8185:2007 + Cor:2008)
Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification Systems
EN ISO 5359:2008 AMD 12011
(ISO 5359:2008 AMD 1 2011)
Low-pressure hose assemblies for use with medical gases
EN ISO 19054:2006
(ISO 19054:2005)
Rail Systems for supporting Medical Equipment
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23558 Lübeck, Germany Postal address:23542 Lübeck, Germany Tel +49 451 882-0 Fax +49 451 882-2080 info@draeger.com www.draeger.com
Bank details:Commerzbank AG, LübeckIBAN DE33 2304 0022 0014 6779 00BIC COBADEFF230Deutsche Bank AG, LübeckIBAN DE85 2307 0710 0031 0003 00BIC DEUTDEHH222
Registered Office: Lübeck Commercial register:Local court Lübeck HRB 7903 HL General partner: Drägerwerk Verwaltungs AG Registered Office: Lübeck Commercial register:'Local court Lübeck HRB 7395 HL
Chairman of the Supervisory Board for Drägerwerk AG & Co. KGaA and Drägerwerk Verwaltungs AG:Prof. Dr. Nikolaus Schweickart Executive Board:Stefan Dräger (chairman)Dr. Herbert Fehrecke Gert-Hartwig Lescow Anton Schrofner
Dräger
EN ISO 80601-2-13:2012
(ISO 80601-2-13:2011)
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic Workstation
EN ISO 17664:2004
(ISO 17664:2004)
Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
EN 980:2008 Symbols for use in the labelling of medical devices
EN1041:2008 Information supplied by the manufacturer of medical devices
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23558 Lübeck, Germany Postal address:23542 Lübeck, Germany Tel +49 451 882-0 Fax +49 451 882-2080 info@draeger.com www.draeger.com
Bank details:Commerzbank AG, LübeckIBAN DE33 2304 0022 0014 6779 00BIC COBADEFF230Deutsche Bank AG, LübeckIBAN DE85 2307 0710 0031 0003 00BIC DEUTDEHH222
Registered Office: Lübeck Commercial register:Local court Lübeck HRB 7903 HL General partner: Drägerwerk Verwaltungs AG Registered Office: Lübeck Commercial register:Local court Lübeck HRB 7395 HL
Chairman of the Supervisory Board for Drägerwerk AG & Co. KGaA and Drägerwerk Verwaltungs AG:Prof. Dr. Nikolaus Schweickart Executive Board:Stefan Dräger (chairman)Dr. Herbert Fehrecke Gert-Hartwig Lescow Anton Schrofner
Dräger
c C 8Appendix II to EC Declaration of Conformity Date / DatumAnlage II zur EG Konformitätserklärung 2018-02-22
U 5 European Directive 93/42/EECEuropäische Richtlinie 93/42/EWG
Document ID / Dokument Nr.MD108-037-1707-176-0-ECA10
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23542 Lübeck Germany
This appendix (II) to EC Declaration of conformity refers to:Die Anlage (II) bezieht sich auf die EG Konformitätserklärung:
MD108-037-1707-176-0
Extent of conformity assessment / Umfang der Konformitätsbewertung
Part No. / Sachnr.
Product name /Produktbezeichnung
MP04557 02-twin-Flowm. 10L, Rail NIST
MP04558 02-Flowmeter 16L, CS DIN
MP04559 AIR-Flowmeter 16L, CS DIN
MP04560 02-twin-Flowmeter 16L, CS DIN
MP04561 02-Flowmeter 16L, CS DIN long
MP04562 AIR-Flowmeter 16L, CS DIN long
MP04563 02-Flowmeter 16L, CS Carba
MP04564 AIR-Flowmeter 16L, CS Carba
MP04565 02-Flowm. 16L, CS Brit. Stand.
MP04566 02-Flowm. 16L.CS French Stand.
MP04567 02-Flowmeter 16L, Rail NIST
MP04568 AIR-Flowmeter 16L, Rail NIST
MP04569 02-twin-Flowm. 16L, Rail NIST
MP04570 02-Flowmeter 16L,Rail 90° NIST
MP04571 02-Flowmeter 32L, CS DIN
Part No. / Sachnr.
Product name /Produktbezeichnung
MP01200 Compact flowmeter
2M86793 Flowmeter with selector wheel
MP01204 Flow proportioning 9/16"
MP05405 CompFlowm.02,rail,15 L, 9/16
MP05406 CompFlowm.02,CS,DIN,2x15L,9/16
MP05407 CompFlowm.AIR,CS,DIN,15L,9/16
MP05408 CompFlowm.AIR,CS,DIN,15L,6mm
MP05409 CompFlowm.AIR,CS,CARBA,15L,6mm
MP04551 02-Flowmeter 4L, CS DIN
MP04552 02-Flowmeter 4L, Rail NIST
MP04553 02-Flowm. 4L, Rail 90° NIST
MP04554 02-Flowmeter 10L CS Carba
MP04555 02-twin-Flowm. 10L, CS Carba
MP04556 02-Flowmeter 10L, Rail NIST
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23558 Lübeck, Germany Postal address:23542 Lübeck, Germany Tel +49 451 882-0 Fax +49 451 882-2080 info@draeger.com www.draeger.com VATno. DE135082211
Bank details:Commerzbank AG, LübeckIBAN DE33 2304 0022 0014 6779 00BIC COBADEFF230Deutsche Bank AG, LübeckIBAN DE85 2307 0710 0031 0003 00BIC DEUTDEHH222
Registered Office: Lübeck Commercial register:Local court Lübeck HRB 7903 HL General partner: Drägerwerk Verwaltungs Registered Office: Lübeck Commercial register:Local court Lübeck HRB 7395 HL
Chairman of the Supervisor^ Board for Drägerwerk AG & Co. KGaA and Drägerwerk Verwaltungs AG:
AG Prof. Dr. Nikolaus Schweickart Executive Board:Stefan Dräger (chairman) Gert-Hartwig Lescow Anton Schrofner
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Dräger
Part No. / Sachnr.
Product name /Produktbezeichnung
MP04572 AIR-Flowmewter 32L, CS DIN
MP04573 02-Flowmeter 16L, hose DIN ISO
MP04574 02-Flowmeter 16L,hose NIST ISO
MP04575 02-Flowm. 16L, hose DIN Neutr
MP04576 02 flowmeter, 16L, NIST ISO, anesthesia
MP04577 02 flowmeter, 16L,NIST neutr.,anesthesia
MP04578 02 flowmeter,90°,16L,NISTISO,anesthesia
MP04579 02 flowmeter,90°,16L,NIST neutr.,anesth.
2M86517 02-Flowmeter 4L, CS
2M86553 02-Flowmeter 16L, CS
2M86554 AIR-Flowmeter 16L, CS
2M86561 02-Twin Flowmeter 16L, CS
2M86562 02-Flowmeter 16L, CS, 9/16 18- UNF
2M86563 02-Flowmeter 16L, CS, TRILUX
2M86564 02-DoubleFlowmeter, 16L, CS,9/16
2M86565 AIR-Flowmeter 16L, CS, long
2M86567 02-Flowmeter 32L, CS
2M86569 AIR-Flowmeter 32L, CS
MP01188 02-Twin-Flowmeter 16L, Rail, 5bar
MP01201 02-Flowmeter 16L, Rail, NIST
MP01202 AIR-Flowmeter 16L, Rail, NIST
Part No. / Sachnr.
Product name /Produktbezeichnung
MP01260 02-Flowmeter 16L, CS, BS
MP01261 02-Flowmeter 16L,CS, NF
MP01262 02-Flowmeter 4L, CS, Japan
MP01263 02-Flowmeter 16L, CS, Japan
MP03391 02-Flowmeter, 10L, CS, Carba,4bar
MP03392 02-Flowmeter, 10L, rail, 4bar
MP03393 02-Flowmeter, 16L, CS, Carba, 4bar
MP03394 02-Flowmeter, 16L, rail, 4bar
MP03395 AIR-Flowmeter, 16L, CS, Carba,4bar
MP03396 AIR-Flowmeter, 16L, rail, 4bar
MP03398 02-Twin-Flowmeter 10L, CS, Carba
MP03399 02-Twin-Flowmeter 10L, Rail, 4bar
2M86516 02 Flowmeter 4L, DIN-tube
2M86248 02 Flowmeter 16L, NIST-tube ISO
2M86249 02 Flowm, 16L, 90 Degrees, NIST- tube ISO
2M86551 02 Flowmeter 16L, DIN-tube ISO
2M86552 Air Flowmeter 16L, DIN-tube ISO
2M86568 02 Flowmeter, 32L, DIN-tube ISO
2M86571 02 Flowm, 16L, 90 Degrees, DIN- tube ISO
2M86575 02 Flowm, 4L, 90 Degrees, DIN- tube ISO
MP01191 02 Flowm, 4L, DIN-tube black
MP01192 02 Flowm., 16L, DIN-tube black
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23558 Lübeck, Germany Postal address:23542 Lübeck, Germany Tel +49 451 882-0 Fax +49 451 882-2080 info@draeger.com www.draeger.com VATno. DE135082211
Bank details:Commerzbank AG, LübeckIBAN DE33 2304 0022 0014 6779 00BIC COBADEFF230Deutsche Bank AG, LübeckIBAN DE85 2307 0710 0031 0003 00BIC DEUTDEHH222
Registered Office: Lübeck Commercial register:Local court Lübeck HRB 7903 HL General partner: Drägerwerk Verwaltungs Registered Office: Lübeck Commercial register:Local court Lübeck HRB 7395 HL
Chairman of the Supervisory Board for Drägerwerk AG & Co. KGaA and Drägerwerk Verwaltungs AG:
AG Prof. Dr. Nikolaus Schweickart Executive Board:Stefan Dräger (chairman) Gert-Hartwig Lescow Anton Schrofner
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Dräger
Part No. / Sachnr.
Product name /Produktbezeichnung
MP01193 Air Flowm., 16L, DIN-tube black
MP01194 02 Flowm., 32L, DIN-tube black
MP01195 Air Flowm., 32L, DIN-tube black
MP01196 02 Flowm, 16L, 90 Degrees, DIN- tube bl.
MP01197 02 Flowm, 4L, 90 Degrees, DIN- tube bl.
MP01198 02 Flowm., 16L, NIST-tube black
MP01199 02 Flowm, 16L, 90 Degrees, NIST- tube bl.
2M16843 Adapter M34x1.5 to M15x1
2M85575 Adapter M32x1.5 to 5mm nozzle
2M85853 Adapter M15x1 to M34x1.5
Part No. / Sachnr.
Product name /Produktbezeichnung
2M86680 Adapter M34x1.5 to 9/16
M06258 Adapter M34x1.5 to 6mm nozzle
MP00416 Adapter 9/16" to 6mm nozzle
MP01184 Adapter for inhalette 02 (M34x1.5 to M15x1)
MP01185 Adapter for inhalette AIR (M32x1.5 to M15x1)
MP03325 Adapter 9/16 to M34
2M85728 Mixing Block
2M85834 Fiumidifier Bubbier
2M85835 Humidifier Nebulizer
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23558 Lübeck, Germany Postal address:23542 Lübeck, Germany Tel +49 451 882-0 Fax +49 451 882-2080 info@draeger.com www.draeger.com VATno. DE135082211
Bank details:Commerzbank AG, LübeckIBAN DE33 2304 0022 0014 6779 00BIC COBADEFF230Deutsche Bank AG, LübeckIBAN DE85 2307 0710 0031 0003 00BIC DEUTDEHH222
Registered Office: Lübeck Commercial register:Local court Lübeck HRB 7903 HL General partner: Drägerwerk Verwaltungs AG Registered Office: Lübeck Commercial register:Local court Lübeck HRB 7395 HL
Chairman of the Supervisory Board for Drägerwerk AG & Co. KGaA and Drägerwerk Verwaltungs AG: Prof. Dr. Nikolaus Schweickart Executive Board:Stefan Dräger (chairman) Gert-Hartwig Lescow Anton Schrofner
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