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

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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