4108 EtCO₂ Nasal Sampling Cannula – Pediatric
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TECHNICAL DATA SHEET 4108 EtCO₂ Nasal Sampling Cannula – Pediatric LATEX FREE | SINGLE PATIENT USE | DISPOSABLE EtCO₂ Nasal Sampling Cannula, Male Slip Tip Device Specifications 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 36306, Carbon Dioxide Nasal Cannula UMDNS Code Product Material Part Description Oxygen Delivery Nasal Face Piece Headset Tubing Polyvinyl Chloride Patient Population Polyvinyl Chloride Disposable, Single Patient Use Acrylonitrile Butadiene Styrene Shelf Life CO₂ Sampling Line Length 2’ (0.6 m) Male Slip Tip Operating Temperature Storage Temperature Intended use: The Nasal CO₂ Sample Line is intended to be used to sample exhaled gas in spontaneously breathing patients requiring expired gas monitoring. Patient population: For use with spontaneously breathing, non-intubated pediatric patients. 4108-2 Description: Over-the-ear style EtCO₂ nasal sampling cannula with a male slip tip connector. 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. 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-10108 Rev 1 Usage: Non-sterile, disposable, single-patient multiple use. 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: Notifies clinicians of change in patient’s ventilatory st