DOC-20001c EU MDR CapnoVue Masks Dec of Conf Rev 1

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

DECLARATION OF CONFORMITY DOC-20001c CapnoVue Masks

2797

SRN: US-MF-000007934 Basic UDI: 006074TF1006c_ETCO2MaskPS

CapnoVue Masks Capnography masks are intended for delivering supplemental oxygen and monitoring exhaled carbon dioxide in non-intubated spontaneously breathing patients.

Product Name: Intended Purpose:

Model Number or Designator:

See the following table of part numbers

DOC-20001c 12 Sept 2022

Control Designator: Device Classification:

Class 2a, Rule 2, according to the (EU) MDR 2017/745, Annex VIII, Chapter I short-term use; Chapter III, Rule 2 non/invasive channeling gases Route of conformity is according to (EU) MDR Annex IX Quality Management System Z12030685 : Vital signs telemetry instrument, consumable 62179, Capnography Oxygen Mask 15230 , Masks, other

Conformity Route:

EMDN Nomenclature code (EMDN) Global Medical Device Nomenclature Code (GMDN) Universal Medical Device Nomenclature System (UMDNS)

Product Options/Accessories:

N/A

EC Certificate – Full Quality Assurance System

MDR 738597

Notified Body:

BSI Group Inc., Notified Body CE 2797 Say Building John M. Keynesplein 9 1066 EP Amsterdam Netherlands www.bsigroup.com

Authorized EU Representative:

MT Promedt Consulting GmbH Ernst-Heckel-Straße 7 66386 St. Ingbert Germany

Revision: 1

Authorized Signature and Function Printed Name: Rob Yamashita,

Date of Issue: 12-Sept-2022

Place of Issue: Regulatory Office, SunMed

Vice President Regulatory

Grand Rapids, Michigan, USA

This declaration of conformity is issued under the sole responsibility of SunMed. We hereby declare that the medical device(s) specified above meet the provision of the Regulation (EU) MDR 2017/745 for medical devices. All technical documentation is retained at the premises of the manufacturer/technical documentation location.

Doc # FRM-10002 Rev 3

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Salter Labs 30 Spur Drive El Paso, TX 79906 USA

DECLARATION OF CONFORMITY DOC-20001c CapnoVue Masks

2797

SRN: US-MF-000007934 Basic UDI: 006074TF1006c_ETCO2MaskPS

Model Number -- Case Qty

CapnoVue Masks

UDI #

CapnoVue M1 Mask (Infant), 7’ O2 line

00607411971327 10607411971324 00607411971310 10607411971317 00607411971280 10607411971287 00607411971273 10607411971270 00607411971303 10607411971300 00607411971297 10607411971294 00607411971372 10607411971379 00607411971341 10607411971348 00607411971372 10607411971331 00607411971365 10607411971355 00607411971358 10607411971355 00607411971419 10607411976305 00607411971402 10607411971409 00607411973116 10607411973113 00607411971396 10607411971393 00607411971389 10607411971386

4721-7-0 4721-7-0-50 4723-7-0 4723-7-0-50 4727-14-0 4727-14-0-50 4727-7-0 4727-7-0-50

CapnoVue M1 Mask (Pediatric), 7’ O2 line.

CapnoVue M1 Mask (Adult), 14’ O2 line

CapnoVue M1 Mask (Adult), 7’ O2 line

CapnoVue M1 Mask (Adult), thread grip, 14’ O2 line

4727TG-14-0 4727TG-14-0-50 4727TG-7-0 4727TG-7-0-50

CapnoVue M1 Mask (Adult), thread grip, 7’ O2 line

CapnoVue Scope Mask (Pediatric), 7’ O2 line

4733-7-0 4733-7-0-50 4737-14-0 4737-14-0-50 4737-7-0 4737-7-0-50

CapnoVue Scope Mask (Pediatric), 14’ O2 line

CapnoVue Scope Mask (Adult), 7’ O2 line

CapnoVue Scope Mask (Adult), thread grip, 14’ O2 line

4737TG-14-0 4737TG-14-0-50 4737TG-7-0 4737TG-7-0-50 4745-14-15 4745-14-15-50 47MSF5-L-7-6 47MSF5-L-7-6-50 47MSF8-14-13 47MSF8-14-13-50 47MSF8-7-6 47MSF8-7-6-50 4745-7-7 4745-7-7-50

CapnoVue Scope Mask (Adult), thread grip, 7’ O2 line

CapnoVue Scope O2/CO2 Mask, luer style connector. 14’ O2 line, 15’ ETCO 2 line CapnoVue Scope O2/CO2 Mask, luer style connector, 7’ O2 line. 7’ ETCO 2 line CapnoVue O2/CO2 Mask, Adult, 7’ O2 line, 6’ CO2 reflective connector line CapnoVue Scope O2/CO2 Mask, reflective connector, 14’ O2 line, 13’ ETCO 2 line CapnoVue Scope O2/CO2 Mask, reflective connector, 7’ O2 line, 6’ ETCO 2 line

Doc # FRM-10002 Rev 3

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