DOC-20006 EU MDR CPAP Cannulaide Dec of Conf Rev 3

DECLARATION OF CONFORMITY DOC-20006

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

SRN: US-MF-000007934 Basic UDI 006074TF1026_CannulaideM4

CPAP Cannulaide

CPAP Cannulaide

Product Name:

Intended Purpose:

CPAP Cannulaide® is a single use, non-sterile device that provides a barrier to protect the nasal area skin on neonates, infants, and children undergoing non-invasive ventilation, while aiding in positioning and securement, and enabling sealing of the nasal interface to the patient.

Model Number or Designator:

See the product table

DOC-20006 12-Sept-2022

Control Designator: Device Classification:

Class 1, Rule 1, according to the European Medical Device Regulation 2017/745, Annex VIII Route of conformity is according to (EU) MDR Annex IX Quality Management System

Conformity Route:

M030302 , Protection System

EMDN Nomenclature code (EMDN)

Global Medical Device Nomenclature Code (GMDN) 44990 , Skin-cover adhesive strip Universal Medical Device Nomenclature System (UMDNS) 10028 , Adhesive strips, hypoallergenic Product Options/Accessories: N/A The Manufacturer is certified by the Notified Body listed below to ISO 13485:2016 & EN ISO 13485:2016 Quality Management System. MD 608599. Notified Body: BSI Group Inc., Notified Body CE 2797 Say Building John M. Keynesplein 9 1066 EP Amsterdam Netherlands www.bsigroup.com

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

Authorized EU Representative:

Revision: 3

Date of Issue: 12-Sep-2022

Authorized Signature and function

Place of Issue: Regulatory Office, SunMed Grand Rapids, Michigan, 49544 USA

Printed Name: Rob Yamashita, VP Regulatory

This declaration of conformity is issued under the sole responsibility of Salter Labs. 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-10001 Rev 3

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DECLARATION OF CONFORMITY DOC-20006

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

SRN: US-MF-000007934 Basic UDI 006074TF1026_CannulaideM4

CPAP Cannulaide

UDIs

Model Number (case qty)

Model Description

10607411007146 10607411007153 10607411007160 10607411007177 10607411007184 10607411007191

CA100-0 (25) CA101-0 (25) CA102-0 (25) CA103-0 (25) CA104-0 (25) CA110-0 (1)

Cannulaide Size 0, for Babies under 700g Cannulaide Size 1, for Babies 700g-1250g Cannulaide Size 2, for Babies 1250g-2000g Cannulaide Size 3, for Babies 2000g-3000g Cannulaide Size 4, for Babies Over 3000g

Cannulaide Variety Pack includes CA100 (3ea) CA101 (7ea) CA102 (10) CA103 (3ea) CA104 (2ea)

Doc # FRM-10001 Rev 3

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