4704F O₂/EtCO₂ Divided Nasal Sampling Cannula – Toddler/Intermediate Infant
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TECHNICAL DATA SHEET 4704F O₂/EtCO₂ Divided Nasal Sampling Cannula – Toddler/Intermediate Infant LATEX FREE | SINGLE PATIENT USE | DISPOSABLE O₂/EtCO₂ Divided Nasal Sampling Cannula, Female Luer, Adaptor Reference Number 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 Oxygen Delivery Benefits: 1) Improve oxygen saturation. 2) Notifies clinicians of change in patient’s ventilatory status. 3) Improves accuracy of EtCO₂ value while delivering oxygen. SunMed LLC/Salter Labs Device Specifications Description CO₂ Sampling Line Internal Diameter CO₂ Sampling Line Length 7’ (2.1 m) CO₂ Line End Connectors Female Luer Style Trumpet, Push-On Patient Population Toddler/Intermediate Infant Disposable, Single Patient Use Operating Temperature Storage Temperature Shelf Life Product Material 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. Part Description Nasal Face Piece Oxygen Tubing Polyvinyl Chloride 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. Polyvinyl Chloride Polyvinyl Chloride Acrylonitrile Butadiene Styrene Patient population: For use with spontaneously breathing, non-intubated infants. 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). 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. Part Number Mercury-Lead: The selected materials do not contain lead or mercury. Description: Over-the-ear style nasal cannula with a divided face piece. Supplemental oxygen is delivered to one nostril, while sampling patients’ exhaled gases from the other nostril. CO₂ sampling line has a female-style luer connector. Packing includes an adaptor,