DOC-20001a EU MDR EtCO2 Cannulas Dec of Conf Rev 1

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DOC-20001a EU MDR EtCO2 Cannulas Dec of Conf Rev 1

[I

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

DECLARATION OF CONFORMITY DOC-20001a EtCO 2 Cannulas

2797

SRN: US-MF-000007934 Basic UDI: 006074TF1006a_ETCO2Can74

EtCO 2 Cannulas The purpose of the EtCO 2 sampling cannulas is to sample exhaled gas during spontaneous breathing to measure the exhaled etCO 2.

Product Name: Intended Purpose:

Model Number or Designator:

See attached

DOC-20001a 12-Sep-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, channeling gases ( EtCO 2 ) Route of conformity is according to (EU) MDR 2017/45 Annex IX Quality Management System Z12030685: Vital signs telemetry instrument, consumable 36306: carbon dioxide nasal cannula 11838 : gas sampling unit

Conformity Route:

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

Product Options/Accessories:

See following table, 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-Sep-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

Page 1 of 12

[I

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

DECLARATION OF CONFORMITY DOC-20001a EtCO 2 Cannulas

2797

SRN: US-MF-000007934 Basic UDI: 006074TF1006a_ETCO2Can74

UDIs

Model Number -- Case Qty

EtCO 2 Cannulas

00607411007057 00607411910883 20607411919194 00607411910845 20607411919217 00607411946424 10607411946421 10607411950916 00607411977794 10607411977807 20607411977811 00607411946431 10607411946438 10607411950893 00607411946363 10607411946360 00607411977824 10607411977869 20607411977842 00607411950902 10607411944953 10607411950909 00607411946356 10607411946346 20607411946367 00607411977855 10607411977869 00607411944963 10607411944960 00607411944994 10607411944991 00607411946400 10607411946407 00607411946264 10607411946261 00607411946271 10607411946278

1220-0-25 13337 13337-25 13347 13347-25

EtCO 2 Female/Male Luer adapter

Adult. EtCO 2 Nasal Cannula, modified nasal prongs, male luer lock connector Adult. EtCO 2 Nasal Cannula, modified nasal prongs, male luer lock connector

4MSF1-0-6 4MSF1-0-6-25 4MSF1-0-6-100 4MSF1-0-6-W 4MSF1-0-6-25-W 4MSF1-0-6-100-W 4MSF1-0-13 4MSF1-0-13-25 4MSF1-0-13-100 4MSF1-7-6-W 4MSF1-7-6-25-W 4MSF1-7-6-100-W 4MSF1-7-13 4MSF1-7-13-25 4MSF1-7-13-100 4MSF1-L-7-6 4MSF1-L-7-6-25 4MSF1-L-7-6-100 4MSF1-L-7-6-W 4MSF1-L-7-6-25-W 4MSF1-L-7-13 4MSF1-L-7-13-25 4MSF2-L-PED-7-13 4MSF2-L-PED-7-13-25 4MSF2-L-PED-7-6 4MSF2-L-PED-7-6-25 4MSF2-PED-7-13 4MSF2-PED-7-13-25 4MSF1-7-6 4MSF1-7-6-25

Adult. EtCO 2 Filtered Oral/Nasal Divided Cannula

Adult. EtCO 2 Filtered Oral/Nasal Divided Cannula, white connector

Adult. EtCO 2 Filtered Oral/Nasal Divided Cannula

Adult. EtCO 2 Filtered Oral/Nasal Divided Cannula.

Adult. EtCO 2 Filtered Oral/Nasal Divided Cannula, white connector

Adult. EtCO 2 Filtered Oral/Nasal Divided Cannula

Adult. EtCO 2 2 Filtered Oral/Nasal Divided Cannula

Adult. EtCO 2 Filtered Oral/Nasal Divided Cannula, white connector

Adult. EtCO 2 Filtered Oral/Nasal Divided Cannula

Pediatric. EtCO 2 Filtered Oral/Nasal Divided Cannula

Pediatric. EtCO 2 Filtered Oral/Nasal Divided Cannula

Pediatric. EtCO 2 Filtered Oral/Nasal Divided Cannula

4MSF2-PED-6 4MSF2-PED-6-25

Pediatric. EtCO 2 Filtered Oral/Nasal Divided Cannula

Doc # FRM-10002 Rev 3

Page 2 of 12

[I

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

DECLARATION OF CONFORMITY DOC-20001a EtCO 2 Cannulas

2797

SRN: US-MF-000007934 Basic UDI: 006074TF1006a_ETCO2Can74

UDIs

Model Number -- Case Qty

EtCO 2 Cannulas

00607411977879 10607411977883 00607411946394 10607411946391 00607411977893 10607411977906 00607411946288 10607411946285 00607411946387 20607411946381 00607411944970 10607411944977 00607411946417 10607411946414 00607411950933 10607411950930 00607411946370 10607411946377 00607411950940 10607411950947 00607411946318 10607411946315 00607411944987 10607411944984 00607411950957 10607411950954 00607411950889 10607411950886 00607411950926 10607411950923 00607411946325 10607411946322 00607411946332 10607411946339 00607411946349 10607411946346 00607411400001 10607411400008 20607411400005 30607411400002

4MSF2-PED-6-W 4MSF2-PED-6-25-W 4MSF2-PED-7-6 4MSF2-PED-7-6-25 4MSF2-PED-7-6-W 4MSF2-PED-7-6-25-W 4MSF3-7-6 4MSF3-7-6-100 4MSF3-7-13 4MSF3-7-13-25 4MSF3-INF-6 4MSF3-INF-6-25 4MSF3-L-6 4MSF3-L-6-25 4MSF3-L-7-6 4MSF3-L-7-6-25 4MSF3-L-INF-6 4MSF3-L-INF-6-25 4MSF3-L-INF-7-6 4MSF3-L-INF-7-6-25 4MSF3-L-INF-13 4MSF3-L-INF-13-25 4MSF3-L-PED-7-6 4MSF3-L-PED-7-6-25 4MSF3-PED-6 4MSF3-PED-6-25 4MSF3-PED-7-6 4MSF3-PED-7-6-25 4MSF3-6 4MSF3-6-25

Pediatric. EtCO 2 Filtered Oral/Nasal Divided Cannula

Pediatric. O 2 / EtCO 2 Filtered Oral/Nasal Divided Cannula

Pediatric. O 2 / EtCO 2 Filtered Oral/Nasal Divided Cannula

Adult. EtCO 2 Filtered Nasal Divided Cannula

Adult O 2 /EtCO 2 Filtered Nasal Divided Cannula

Adult. O 2 /EtCO 2 Filtered Nasal Divided Cannula

Infant. EtCO 2 Filtered Nasal Sampling Cannula

Adult. EtCO 2 Filtered Nasal Divided Cannula

Adult. EtCO 2 Filtered Nasal Divided Cannula

Infant EtCO 2 Filtered Nasal Sampling Cannula

Infant. EtCO 2 Filtered Nasal Divided Cannula, Nafion moisture reduction technology for prolonged duration use. Infant. EtCO 2 Filtered Nasal Divided Cannula, Nafion moisture reduction technology Pediatric. EtCO 2 Filtered Nasal Divided Cannula, Nafion moisture reduction technology

Pediatric. EtCO 2 Filtered Nasal Divided Cannula

Pediatric. EtCO 2 Filtered Nasal Divided Cannula

4MSN1-7-6 4MSN1-7-6-25 4MSN3-6 4MSN3-6-25 4MSN3-7-6 4MSN3-7-6-25

Adult. EtCO 2 Oral/Nasal Divided Cannula

Adult. EtCO 2 Nasal Sampling Cannula

Adult. O2/EtCO 2 Nasal Divided Cannula

4000-7 4000-7-10 4000-7-25 4007-7-250

Adult. EtCO 2 Nasal Sampling Cannula, male luer style connector

Doc # FRM-10002 Rev 3

Page 3 of 12

[I

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

DECLARATION OF CONFORMITY DOC-20001a EtCO 2 Cannulas

2797

SRN: US-MF-000007934 Basic UDI: 006074TF1006a_ETCO2Can74

UDIs

Model Number -- Case Qty

EtCO 2 Cannulas

00607411401022 10607411401029 00607411400018 10607411400015 20607411400012 00607411400025 10607411400022 20607411400029 00607411400032 20607411400036 00607411400046 10607411400049 20607411400043 00607411918414 10607411918411 00607411918452 10607411918459 00607411918445 10607411918442 00607411400056 10607411400053 20607411400050 00607411918438 10607411918435 00607411006982 10607411006989 00607411400070 10607411400077 00607411400087 10607411400084 00607411400094 20607411400098 00607411400124 10607411400121 20607411400128 00607411401008 10607411401005 00607411400131 10607411400138

4000F-2 400F-2-25 4000F-7 4000F-7-10 4000F-7-25 4001-7 4001-7-10 4001-7-50 4001F-7 4001F-7-25 4002-7-7 4002-7-7-10 4002-7-7-25

Adult. EtCO 2 Nasal Sampling Cannula, female luer style connector

Adult. EtCO 2 Nasal Sampling Cannula, female luer style connector

Adult. EtCO 2 Oral/Nasal Sampling Cannula, male luer style connector

Adult. EtCO 2 Oral/Nasal Sampling Cannula, female luer style connector Adult. EtCO 2 /O 2 Nasal Sampling Cannula, male luer style connector

4002-10-10 4002-10-10-25 4002-14-14 4002-14-14-25 4002F-7-0 4002F-7-25 4002F-7-7-0 4002F-7-7-10 4002F-7-7-25 4002F-10-10 4002F-10-10-25 4003-7-7-0 4003-7-7-25 4003F-7-7-0 4003F-7-7-25

Adult. EtCO 2 /O 2 Nasal Sampling Cannula, male luer style connector

Adult. EtCO 2 /O 2 Nasal Sampling Cannula, male luer style connector

Adult. EtCO 2 /O 2 Nasal Sampling Cannula, female luer style connector Adult. EtCO 2 /O 2 Nasal Sampling Cannula, female luer style connector Adult. EtCO 2 /O 2 Nasal Sampling Cannula, female luer style connector Adult. EtCO 2 /O 2 Oral/Nasal Cannula, male luer style connector

Adult. EtCO 2 /O 2 Oral/Nasal Cannula, female luer style connector

4007-7 4007-25

Adult, EtCO 2 Nasal Sampling Cannula, male slip tip connector , filter

4008-2 4008-2-25 4100-7 4100-7-10 4100-7-25 4100F-2 4100F-2-25 4100F-7 4100F-7-25

Adult. EtCO 2 Nasal Sampling Cannula, male luer style connector

Pediatric. EtCO 2 Nasal Sampling Cannula, male luer style connector

Pediatric. EtCO 2 Sampling Cannula, female luer style connector

Pediatric. EtCO 2 Sampling Cannula, female luer style connector

Doc # FRM-10002 Rev 3

Page 4 of 12

[I

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

DECLARATION OF CONFORMITY DOC-20001a EtCO 2 Cannulas

2797

SRN: US-MF-000007934 Basic UDI: 006074TF1006a_ETCO2Can74

UDIs

Model Number -- Case Qty

EtCO 2 Cannulas

00607411400148 10607411400145 20607411400142 00607411400162 20607411400166 00607411801211 10607411801218 00607411400209 10607411400206 20607411400203 00607411400223 10607411400220 20607411400227 00607411400230 10607411400237 00607411400247 20607411400241 00607411400254 10607411400251 00607411400261 20607411400265 00607411400391 10607411400398 20607411400395 00607411400407 10607411400404 20607411400401 00607411400414 20607411400418 00607411400421 10607411400428 20607411400425 00607411400438 10607411400435 00607411000263 10607411000260 20607411000267 00607411400452 10607411400459 20607411400456

4101-7 4101-7-10 4101-7-25 4102-7-7 4102-7-7-25 4102F-7-7-0 4102F-7-7-25 4108-2 4108-2-10 4108-2-25 4200-7 4200-7-10 4200-7-25 4200F-7 4200F-7-25 4208-2 4208-2-25 4300-7 4300-7-25 4300F-7 4300F-7-25 4700-7-7 4700-7-7-10 4700-7-7-25 4700F-7-7 4700F-7-7-10 4700F-7-7-25 4701-7-0 4701-7-0-25 4701F-7-0 4701F-7-0-10 4701F-7-0-25 4702-7-0 4702-7-0-25 4702F-7-0 4702F-7-0-10 4702F-7-0-25 4703-7-7 4703-7-7-10 4703-7-7-25

Pediatric. EtCO 2 Oral/Nasal Sampling Cannula, male luer style connector

Pediatric. EtCO 2 / Nasal Sampling Cannula, male luer style connector

Pediatric. EtCO 2 /O 2 Nasal Cannula, female luer style connector

Pediatric. EtCO 2 Nasal Sampling Cannula, male luer style connector

Infant. EtCO 2 Nasal Divided Cannula, male luer style connector

Infant. EtCO 2 Nasal Sampling Cannula, female luer style connector

Infant. EtCO 2 Nasal Sampling Cannula, male slip tip connector

Intermediate Infant. EtCO 2 Nasal Sampling cannula, female luer style connector Intermediate Infant. EtCO 2 Nasal Sampling cannula, female luer style connector Infant. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector

Infant. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector

Infant. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Infant. EtCO 2 /O2 Nasal Divided Cannula, female luer style connector

Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Doc # FRM-10002 Rev 3

Page 5 of 12

[I

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

DECLARATION OF CONFORMITY DOC-20001a EtCO 2 Cannulas

2797

SRN: US-MF-000007934 Basic UDI: 006074TF1006a_ETCO2Can74

UDIs

Model Number -- Case Qty 4703F-7-7 4703F-7-7-10 4703F-7-7-25 4703FTG-7-7 4703FTG-7-7-25 4703TG-7-7 4703TG-7-7-25

EtCO 2 Cannulas

00607411000270 10607411000277 20607411000274 00607411400643 10607411400640 00607411940767 10607411940764 00607411400698 20607411400692 00607411400704 10607411400701 20607411400708 00607411400476 20607411400470 0607411400483 10607411400480 00607411400506 10607411400503 20607411400500 00607411400513 10607411400517 20607411400510 00607411400520 10607411400527 00607411940743 10607411940740 00607411401978 10607411401975 00607411401060 10607411401067 00607411400544 10607411400541 20607411400548 00607411401985 10607411401982 00607411400551 10607411400558 20607411400555 00607411400575 10607411400572

Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, female thread grip, female luer style connector Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector, female thread grip connector Intermediate Infant. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector Intermediate Infant. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector Intermediate Infant. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector Intermediate Infant. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

4704-7-7 4704-7-7-25 4704F-7-7 4704F-7-7-10 4704F-7-7-25 4705-7-0 4705-7-0-25 4705F-7-0 4705F-7-0-25 4706-7-0 4706-7-0-10 4716-7-0-25 4706F-7-0 4706F-7-0-10 4706F-7-0-25

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

4706FTG-7-0 4706FTG-7-0-25 4706TG-7-0 4706TG-7-0-25 4707-10-10 4707-10-10-25 4707-13-13 4707-13-13-25 4707F-14-14 4707F-14-14-25 4707F-7-7 4707F-7-7-10 4707F-7-7-25 4707FTG-7-7 4707FTG-7-7-25 4707-7-7 4707-7-7-10 4707-7-7-25

Adult. EtCO 2 /O 2 Nasal Divided Cannula, female thread grip and female luer style connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, female thread grip, female luer style connector

Doc # FRM-10002 Rev 3

Page 6 of 12

[I

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

DECLARATION OF CONFORMITY DOC-20001a EtCO 2 Cannulas

2797

SRN: US-MF-000007934 Basic UDI: 006074TF1006a_ETCO2Can74

UDIs

Model Number -- Case Qty 4707FTG-10-10 4707FTG-10-10-25 4707SP-7-7 4707SP-7-7-25 4707TG-7-7 4707TG-7-7-25 4707TG-10-10 4707TG-10-10-25 4707TG-13-13 4707TG-13-13-25 4707TG-14-14 4707TG-14-14-25 4708-7-2 4708-7-2-25 4783-7-2 4783-7-2-25 4787-7-2 4787-7-2-25 4793-7-7 4793-7-7-10 4793-7-7-25 4793F-7-7 4793F-7-7-25 4796F-7-0 4796F-7-0-25 4797-7-7 4797-7-7-10 4797-7-7-25 4797F-7-7- 4797F-7-7-10 4797F-7-7-25 4797SP-7-7 4797SP-7-7-25 4797TG-7-7 4797TG-7-7-25 47SOFT-10-10 47SOFT-10-10-25 47SOFT-13-13 47SOFT-13-13-25

EtCO 2 Cannulas

00607411940750 10607411940757 00607411401251 10607411401258 00607411961342 10607411961349 00607411951237 10607411951234 00607411947353 10607411947350 00607411940774 10607411940771 00607411400582 20607411400586 00607411400599 10607411400596 00607411400605 10607411400609 00607411401015 10607411401012 20607411401019 00607411401039 20607411401033 00607411400940 10607411400947 00607411400957 10607411400954 20607411400951 00607411400964 10607411400961 20607411400968 00607411401268 10607411401265 00607411947360 10607411947367 00607411947148 10607411947145 00607411945380 10607411945387

Adult. EtCO 2 /O 2 Nasal Divided Cannula, female thread grip connector, female luer style connector Adult EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector and filter Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula. Male luer style connector, thread grip connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector Adult EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector, filter Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, male slip tip connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male slip tip connector

Pediatric. EtCO 2 /O 2 Oral-Trac Divided Cannula, male luer style connector

Pediatric. EtCO 2 Oral-Trac Divided Cannula, female luer style connector Adult. EtCO 2 Oral-Trac Divided Cannula, female luer style connector

Adult. EtCO 2 /O 2 Oral/Nasal Divided Cannula, male luer style connector and filter

Adult. EtCO 2 /O 2 Oral/Nasal Divided Cannula, female luer style connector

Adult. EtCO 2 /O 2 Oral/Nasal Divided Cannula, male luer style connector and filter Adult. EtCO 2 /O 2 Divided Cannula. Male luer style connector, thread grip connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Doc # FRM-10002 Rev 3

Page 7 of 12

[I

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

DECLARATION OF CONFORMITY DOC-20001a EtCO 2 Cannulas

2797

SRN: US-MF-000007934 Basic UDI: 006074TF1006a_ETCO2Can74

UDIs

Model Number -- Case Qty 47SOFT-7-0 47SOFT-7-0-25 47SOFT-7-7 47SOFT-7-7-25

EtCO 2 Cannulas

00607411945830 10607411945837 00607411945762 10607411945769 00607411946721 10607411946728 00607411946738 10607411946735 00607411945793 10607411945790 00607411947100 10607411947107 00607411945779 10607411945776 00607411401312 10607411401319 00607411946745 10607411946742 00607411947155 10607411947152 00607411946752 10607411946759 00607411946721 10607411951234 00607411946738 10607411946735 00607411946769 10607411946766 00607411946707 10607411946704 00607411946714 10607411946711 00607411401329 10607411401326 00607411945403 10607411945400 00607411946691 10607411946698

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

47SOFT-F-PED-7-0 47SOFT-F-PED-7-0-25 47SOFT-F-PED-7-7 47SOFT-F-PED-7-7-25 47SOFT-F-14-14 47SOFT-F-14-14-25

Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector

47SOFT-F-7-0 47SOFT-F-7-0-25 47SOFT-F-7-7 47SOFT-F-7-7-25

Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector

47SOFT-FTG-10-10 47SOFT-FTG-10-10-25 47SOFT-FTG-7-0 47SOFT-FTG-7-0-25 47SOFT-FTG-7-7 47SOFT-FTG-7-7-25 47SOFT-FTG-PED-7-7 47SOFT-FTG-PED-7-7-25 47SOFT-F-PED-7-0 47SOFT-F-PED-7-0-25 47SOFT-F-PED-7-7 47SOFT-F-PED-7-7-25 47SOFT-PED-7-0 47SOFT-PED-7-0-25 47SOFT-PED-7-2 47SOFT-PED-7-2-25 47SOFT-PED-7-7 47SOFT-PED-7-7-25 47SOFT-SP-7-7 47SOFT-SP-7-7-25 47SOFT-TG-10-10 47SOFT-TG-10-10-25 47SOFT-TG-7-0 47SOFT-TG-7-0-25

Adult. EtCO 2 /O 2 Nasal Divided Cannula female thread grip connector, female luer style connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, female thread grip connector, female luer style connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, female thread grip connector, female luer style connector Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, thread grip connector, female luer style connector Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, thread grip connector, female luer style connector Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, male slip tip connector

Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Adult EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector, filter Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector, thread grip connector

Doc # FRM-10002 Rev 3

Page 8 of 12

[I

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

DECLARATION OF CONFORMITY DOC-20001a EtCO 2 Cannulas

2797

SRN: US-MF-000007934 Basic UDI: 006074TF1006a_ETCO2Can74

UDIs

Model Number -- Case Qty 47SOFT-TG-7-7 47SOFT-TG-7-7-25 47SOFT-TG-14-14 47SOFT-TG-14-14-25 47SOFT-TG-PED-7-7 47SOFT-TG-PED-7-7-25

EtCO 2 Cannulas

00607411945786 10607411945783 00607411946684 10607411946681 00607411401381 10607411401388 00607411400612 10607411400619 00607411301728 10607411301725 20607411301722 00607411301735 10607411301732 00607411301704 10607411301701 00607411301681 10607411301688 20607411301685 00607411301759 10607411301756 00607411301742 10607411301749 00607411301711 10607411301718 00607411301698 10607411301695 00607411945748 10607411945745 00607411945755 10607411945752 00607411961373 10607411961370 00607411919152 10607411919159 00607411951220 10607411951227 00607411401336 10607411401333

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector, thread grip connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector, thread grip connector Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

4801-2 4801-2-25

Adult. EtCO 2 /O 2 /Nasal Dividend Cannula, male luer style connector

4950-10-10 4950-10-10-25 4950-10-10-50 4950-14-14 4950-14-14-25

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

4950-7-0 4950-7-0-25 4950-7-7 4950-7-7-25 4950-7-7-50

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

4950F-10-10 4950F-10-10-25 4950F-14-14 4950F-14-14-25

Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector

4950F-7-0 4950F-7-0-25 4950F-7-7 4950F-7-7-25

Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector

4950FTG-10-10 4950FTG-10-10-25 4950FTG-7-7 4950FTG-7-7-25 4950TG-7-7 4950TG-7-7-25 4950TG-10-10 4950TG-10-10-25 4950TG-14-14 4950TG-14-14-25 49SOFT-7-0 49SOFT-7-0-25

Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector, thread grip connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector, thread grip connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector, thread grip connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector, thread grip connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector, thread grip connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style CO2 connector

Doc # FRM-10002 Rev 3

Page 9 of 12

[I

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

DECLARATION OF CONFORMITY DOC-20001a EtCO 2 Cannulas

2797

SRN: US-MF-000007934 Basic UDI: 006074TF1006a_ETCO2Can74

UDIs

Model Number -- Case Qty

EtCO 2 Cannulas

00607411945397 10607411945394 00607411945809 10607411945806 00607411945816 10607411945813 00607411947117 10607411947114 00607411401398 10607411401395 00607411945823 10607411945820 00607411947162 10607411947169 00607411401367 10607411401364 00607411401343 10607411401340 00607411945410 10607411945417 00607411947124 10607411947121 00607411947131 10607411947138 00607411400902 10607411400909 00607411004407 10607411004404 00607411006975 10607411006972 00607411951183 10607411951180 00607411951169 10607411951166 00607411951145 10607411951142 00607411951176 10607411951173

49SOFT-7-7 49SOFT-7-7-25 49SOFT-10-10 49SOFT-10-10-25 49SOFT-14-14 49SOFT-14-14-25 49SOFT-F-10-10 49SOFT-F-10-10-25 49SOFT-F-7-0 49SOFT-F-7-0-25 49SOFT-F-7-7 49SOFT-F-7-7-25 49SOFT-F-14-14 49SOFT-F-14-14-25 49SOFT-FTG-10-10 49SOFT-FTG-10-10-25 49SOFT-FTG-7-7 49SOFT-FTG-7-7-25 49SOFT-TG-7-7 49SOFT-TG-7-7-25 49SOFT-TG-10-10 49SOFT-TG-10-10-25 49SOFT-TG-14-14 49SOFT-TG-14-14-25 SEN115 (SO-1200) SEN115-250 SEN116B (SO-1942) SEN116B-250 (SO-2038) SH34281 (SO-2038-25) (SO-2039) SH34282 (SO-2039-25) (SO-2040) SH34283 (SO-2040-25) (SO-2041) SH34284 (SO-2041-25) SO-1135 SO-1135-25

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style CO2 connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style CO2 connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style CO2 connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style CO2 connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style CO2 connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style CO2 connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style CO2 connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, thread grip connector, female luer style CO2 connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, thread grip connector, female luer style CO2 connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style CO2 connector, thread grip connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector, thread grip connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector, thread grip connector Adult. EtCO 2 Divided Capnography Cannula, male luer style connector Adult. EtCO 2 Nasal Sampling Cannula, male luer style connector

Pediatric. EtCO 2 Nasal Sampling Cannula, male luer style connector

Adult. EtCO 2 Nasal Divided Cannula, male luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector

Doc # FRM-10002 Rev 3

Page 10 of 12

[I

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

DECLARATION OF CONFORMITY DOC-20001a EtCO 2 Cannulas

2797

SRN: US-MF-000007934 Basic UDI: 006074TF1006a_ETCO2Can74

UDIs

Model Number -- Case Qty SO-1650 (9012) SO-1650-25 SO-1651-7 (9013) SO-1651-7-25 SO-1652 (9014) SO-1650-25 SO-1653 (9015) SO-1653-25 SO-1654 (9016) SO-1654-25 SO-1655 (9016A) SO-1655-25 SO-1656 (9016B) SO-1656-25 SO-1657 (9016C) SO-1657-25 SO-2036-7 SO-2036-7-25 SO-2036-14 SO-2036-14-25 SO-2036F-10 SO-2036F-10-25 SO-2036F-7 SO-2036F-7-25

EtCO 2 Cannulas

00607411201509 10607411201506 00607411201516 10607411201513 00607411201523 10607411201520 00607411201530 10607411201537 00607411201547 10607411201544 00607411201554 10607411201551 00607411201561 10607411201568 00607411201578 10607411201575 00607411102035 10607411102032 00607411102059 10607411102070 00607411102295 10607411102292 00607411102271 10607411102278 00607411889639 10607411889636 00607411889066 10607411889063 00607411400711 10607411400718 00607411400759 10607411400756 20607411400760 00607411400780 20607411400780 00607411400773 10607411400770

Adult. EtCO 2 Nasal Sampling Cannula, female luer style

Pediatric. EtCO 2 Nasal Sampling Cannula, female luer style

Infant. EtCO 2 Nasal Sampling Cannula, female luer style

Intermediate Infant. EtCO 2 Nasal Sampling Cannula, female luer style connector Adult. Nasal Cannula Salter Style, modified nasal prongs, female luer style connector Infant. EtCO 2 Nasal Divided cannula, female luer style connector Intermediate Infant. ETCO2 Nasal Divided cannula, female luer style connector Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector Adult. EtCO 2 Divided SOFT Capnography Cannula, male luer style connector Adult. EtCO 2 Divided SOFT Capnography Cannula, male luer style connector Adult. EtCO 2 Divided Capnography Cannula, female luer style connector Adult. EtCO 2 Divided Capnography Cannula, male luer style connector Adult. Divided Sampling Capnography Cannula, male luer style connector Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector

SO-396 SO-396-100

SO-426-14-14 SO-426-14-14-25

SO-431 SO-431-25

Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector

SO-438 SO-438-9-9-25 SO-443-10-10-25

Adult. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector Pediatric. EtCO 2 /O 2 Nasal Divided Cannula, female luer style connector Adult EtCO 2 /O 2 Nasal Divided Cannula, female luer style CO2 connector

SO-444 SO-444-25

SO-449-14-14 SO-449-14-14-25

Doc # FRM-10002 Rev 3

Page 11 of 12

[I

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

DECLARATION OF CONFORMITY DOC-20001a EtCO 2 Cannulas

2797

SRN: US-MF-000007934 Basic UDI: 006074TF1006a_ETCO2Can74

UDIs

Model Number -- Case Qty

EtCO 2 Cannulas

00607411889639 10607411400858 20607411400858 00607411400735 10607411400732

SO-686 SO-686-10 SO-686-25

Adult. EtCO 2 Nasal Cannula, male luer style connector

T4707-7-7 T4707-7-7-25

Adult. EtCO 2 /O 2 Nasal Divided Cannula, male luer style connector, tender grip connector

Doc # FRM-10002 Rev 3

Page 12 of 12

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