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

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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