TECHNICAL DATA SHEET 49SOFT-F-7-0 O₂/EtCO₂ Divided Nasal Sampling Cannula, Adult LATEX FREE | SINGLE PATIENT USE | DISPOSABLE O₂/EtCO₂ Divided Nasal Sampling Cannula, Female Luer, Adaptor Device Specifications Description Reference Number SunMed LLC/Salter Labs CO₂ Sampling Line Internal Diameter Product Code CCK Analyzer, Gas Carbon-Dioxide, Gaseous-Phase CE Mark / Notified Body Class I, Rule 2 EU MDR 2017/745 Annex VIII EMDN code R9099, Respiratory and Anesthesia Devices, Other Z120306, Vital Signs Monitoring Instrument GMDN Code CO₂ Sampling Line Length 2” (0.05 m) Female Luer Style 36306, Carbon Dioxide Nasal Cannula Trumpet, Push-On UMDNS Code Operating Temperature Oxygen Delivery Storage Temperature Patient Population Product Material Disposable, Single Patient Use Part Description Nasal Face Piece Shelf life Soft Headset Tubing Soft Durometer Polyvinyl Chloride, 3-Channel Oxygen Tubing Polyvinyl Chloride Device Description: Over-the-ear style nasal cannula with a divided face piece and soft 3-Channel headset tubing. Supplemental oxygen is delivered to one nostril, while sampling patients exhaled gases from the other nostril. Packing includes an oxygen adaptor, 22 mm x 6 mm. Polyvinyl Chloride Polyvinyl Chloride Acrylonitrile Butadiene Styrene Intended use: The O₂ Delivery / CO₂ Sampling Nasal Cannula is intended to be used with spontaneous breathing patients who require simultaneous low flow oxygen delivery and exhaled gas sampling. Part Number Patient population: For use with non-intubated adult patients. Area of use: Locations where procedures are performed where the patient requires monitoring of exhaled gases e.g. procedural sedation, lower GI procedures, EMS, or surgical cases. Used in hospital, sub-acute, and pre-hospital settings. Contraindications: No known. Benefits: 1) Improves oxygen saturation 2) Notifies clinicians of change in patient’s ventilatory status 3) Improves accuracy of EtCO₂ value while delivering oxygen. 4) Soft headset tubing improves patient comfort. Latex: SunMed® does not utilize latex or latex-containing material to manufacture products. To the best of our knowledge latex does not contact components or finished goods during the manufacturing process. Phthalates: The selected materials are Non-DEHP; DEHP was not intentionally added as part of the manufacturing process. Mercury-Lead: The selected materials do not contain lead or mercury. Biocompatible per device classification in ISO 10993. SunMed manufactures product from medical grade materials in compliance with Good Manufacturing Practices (GMPs) as listed in 21 C.F.R. (U.S. Code of Federal Regulations).