DOC-20010 EU MDR Sleep Diag Cannula Dec of Conf Rev 3

DECLARATION OF CONFORMITY DOC-20010 Sleep Diagnostic Cannulas

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

SRN: US-MF-000007934 Basic UDI 006074TF013_SleepXcann6E

Sleep Diagnostic Cannulas

Product Name:

Intended Purpose:

The nasal cannula directs airflow and pressure waves generated by breathing and snoring to the transducers; aiding in sleep diagnostic procedures.

Model Number or Designator:

See attached

DOC-20010 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:

Z12030685, Vital Signs Telemetry Consumables 35194 , Respiratory Apnea Monitoring System 12575 , Apnea Monitors

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

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

Authorized EU Representative:

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

Revision: 2

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

Page 1 of 3

DECLARATION OF CONFORMITY DOC-20010 Sleep Diagnostic Cannulas

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

SRN: US-MF-000007934 Basic UDI 006074TF013_SleepXcann6E

UDIs

Model Number -- Case Qty

Description

00607411 00098 00607411500015 10607411500012 00607411500596 10607411500593 00607411000881 10607411000888 00607411500626 10607411500623 00607411500602 10607411500609 00607411500022 10607411500029 00607411500244 10607411500241 00607411500251 10607411500258 00607411007972 10607411007979 20607411007419 00607411007965 10607411007962 00607411500138 10607411500135 00607411500268 10607411500265 20607411500262 00607411500145 10607411500142 00607411500107 10607411500104 00607411500213 10607411500210 00607411005404 10607411005401 00607411005381 10607411005388 20607411005385 00607411005374 10607411005371 20607411005378

1001-0-25 5001-7 5001-7-25 5005-7 5005-7-25 5006-1 5006-1-25 5006-2 5006-2-25 5006-7 5006-7-25 5008-7-7 5087-7-7-25 5009-7-7 5009-7-7-25 5010-7-7 5010-7-7-25 5011-1 5011-1-25 5011-1-100 5011-2 5011-2-25 5011-7 5011-7-25 5012-1 5012-1-25 5012-1-50 5012-7 5012-7-25 5022-7 5022-7-25 5034-7 5034-7-25 5036-7 5036-7-10 5037-7 5037-7-10 5037-7-25 5038-7 5038-7-10 5083-7-25

Filter

Adult. Oral/Nasal Pressure Monitoring Cannula, 7' (2.1 m) tube, filter.

Adult. Oral/Nasal Pressure Monitoring Cannula, 7’ (2.1 m) tube, filter.

Adult. Oral/Nasal Pressure Monitoring Cannula, 1' (0.3 m) tube, male luer style connector Adult. Oral/Nasal Pressure Monitoring Cannula, 2' (0.6 m) tube, male luer style connector Adult. Oral/Nasal Pressure Monitoring Cannula, 7' (2.1 m) tube, male luer style connector Adult. Divided Oral/Nasal Pressure Monitoring Gas Sampling Cannula, 7’ (2.1 m) tubes, male/female connector (gas sampling), filter for pressure monitoring Pediatric. Divided Oral/Nasal Pressure Monitoring Gas Sampling Cannula, 7' (2.1 m) tubes, male/female connector (gas sampling), filter (pressure monitoring) Pediatric. Divided Oral/Nasal Pressure Monitoring & Gas Sampling Cannula, 7’ (2.1 m) tubes, male/female connector (gas sampling), male luer connector (pressure monitoring)

Adult. Nasal Pressure Monitoring Cannula,1' (.3 m) tube, filter

Adult. Nasal Pressure Monitoring Cannula, 2' (.6 m) tube, filter

Adult. Nasal Pressure Monitoring Cannula, 7' (2.1 m) tube, filter

Adult. Nasal Pressure Monitoring Cannula, 1' (0.3 m), male luer style connector

Adul.t Nasal Pressure Monitoring Cannula , 7' (2.1 m) tube, male luer style connector Pediatric. Nasal Pressure Monitoring Cannula , 7' (2.1 m) tube, male luer style connector Pediatric. Oral/Nasal Pressure Monitoring Cannula, 7’ (2.1 m) tube, male luer style connector Pediatric. (Small) Oral/Nasal Pressure Monitoring Cannula, 7' (2.1 m) tube, male luer-lock connector Pediatric. Oral/Nasal Pressure Monitoring Cannula,7’ (2.1 m) tube, filter

Pediatric. Oral/Nasal Pressure Monitoring Cannula, 7’ (2.1 m) tube, male luer style connector

Doc # FRM-10001 Rev 3

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DECLARATION OF CONFORMITY DOC-20010 Sleep Diagnostic Cannulas

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

SRN: US-MF-000007934 Basic UDI 006074TF013_SleepXcann6E

UDIs

Model Number -- Case Qty

Description

00607411500350 10607411500357 00607411500398 10607411500395 00607411500442 10607411500449 00607411500367 10607411500364 00607411500404 10607411500401 00607411500473 10607411500470 00607411500411 10607411500418 00607411500466 10607411500463 00607411801105 10607411801102

5041-7-7 5041-7-7-25 5042-7-7 5042-7-7-25 5044-7-7 5044-7-7-25 5049-7-7 5049-7-7-25 5050-7-7 5050-7-7-25 5052-7-7 5027-7-7-25 5054-7-7 5054-7-7-25 5056-7-7 5056-7-7-25 SO-1990 SO-1990-50

Adult. Nasal Pressure Monitoring Gas Sampling Cannula, 7’ (2.1 m) tubes, male/female connector Adult. Nasal Pressure Monitoring Gas Sampling Cannula, 7’ (2.1 m) tubes, male/female connector Adult. Oral/Nasal Pressure monitoring Gas Sampling Cannula, 7’ (2.1 m) tubes, male/female connector Pediatric. Nasal Pressure Monitoring Gas Sampling Cannula,7’ (2.1 m) tubes, male/female connector Pediatric. Nasal Pressure Monitoring Gas Sampling Cannula, 7’ (2.1 m) tubes, male/female connector Pediatric. Oral/Nasal Pressure Monitoring & Gas Sampling Cannula, 7’ (2.1 m) tubes, male/female connector Small Pediatric. Nasal Pressure Monitoring Gas Sampling Cannula, 7’ (2.1 m) tubes, male/female connector Small Pediatric. Oral/Nasal Pressure Monitoring Gas Sampling Cannula, 7’ (2.1 m) tubes, male/female connector

Adult. Nasal Pressure Monitoring, 7 1/4"(0.184 m) tube, filter

Doc # FRM-10001 Rev 3

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