TECHNICAL DATA SHEET 4MSF3-L-6 O₂/EtCO₂ Nasal Sampling Cannula – Long Term Use LATEX FREE | SINGLE PATIENT USE | DISPOSABLE O₂/EtCO₂ Nasal Sampling Cannula Device Specifications Reference Number SunMed LLC/Salter Labs Product Code Code CCK – Carbon Dioxide Gas Analyzer Class II, Conformity Assessment Route: Medical Device License CE Mark / Notified Body Class IIa, Rule 2, EU MDR 2017/745, Annex VIII EMDN Code R9099 Respiratory and Anesthesia Devices, other Z120306 Vital Signs Monitoring Consumables GMDN Code 36306, Carbon-Dioxide – Sampling Nasal Oxygen Cannula UMDNS Code 11838, Cannulae, Nasal Oxygen. Oxygen Delivery Patient Population Disposable, Single Patient Multiple Use Shelf Life CO₂ Sampling Line Internal Diameter 0.040" (1.02 mm) CO₂ Sampling Line Length CO₂ Sampling Line End Connectors Female Reflective CO₂ Sampling Line Filter Operating Temperature Storage Temperature Product Material Material Nasal Face Piece Polyvinyl Chloride Acrylonitrile Butadiene Styrene Moisture Management Filter Outer Acrylonitrile Butadiene Styrene Filter Media Hydrophobic Polypropylene Membrane UOM 4MSF3-L-6-25 Intended use: The O₂/EtCO₂ Nasal Sampling Cannula is intended to be used to deliver low flow oxygen, and to monitor exhaled CO₂ in a spontaneously breathing patient. Part Number 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 and ISO 18562. 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). TDS-10211 Rev 1 Part Description Duration: Includes Nafion tubing for use in high humidity environment or long-term use. Monitors: Reflective technology. For use with capnography monitors and modules that utilize Microstream technology. 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. Hospital, sub-acute, medical clinic, pre-hospital, surgical centers. Contraindications: No known. Caution: Keep tubing straight and free of kinks. Do