TECHNICAL DATA SHEET 1606BTLC Adult Nasal Cannula with Ear Wraps and Barbed Connector LATEX FREE | SINGLE PATIENT USE | DISPOSABLE Salter-Style® 1600 Adult Nasal Cannula Device Specifications Description Oxygen Tubing Length Oxygen Flow Rate Plastic Tubing Operating Temperature Storage Temperature Reference Number SunMed LLC/Salter Labs Class I Medical Device CAT – Nasal Oxygen Cannula Class II, Conformity Assessment Route: Medical Device License Class IIa, Rule 2 , MDR 2017/745, Annex VIII Product Material EMDN Code R03010203, Air/Oxygen Nasal Cannula Part Description GMDN Code Nasal Face Piece Plastisol, Reddish Tint UMDNS Code 12799, Cannulae, Nasal Oxygen Oxygen Tubing Disposable, Single Patient Multiple Use Headset Tubing Polyvinyl Chloride, Smooth Bore Patient Population Polyvinyl Chloride Area of use: Hospitals, medical clinics, home, surgical centers, skilled nursing facilities. Duration of use: Discard and replace nasal cannula every 14 days or sooner if the cannula becomes soiled or damaged. Contraindications: No known. Caution: Keep tubing straight and free of kinks. Do not sterilize. Warning: • If patient develops infection, skin irritation or material sensitization consult physician. Patient may become hypoxic if oxygen flow is interrupted. Position tubing to avoid strangulation or tripping hazard. Do not place anything on oxygen tubing that may obstruct flow. 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. Salter Labs 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). Part Number Use oxygen product as prescribed. Latex: Salter Labs® does not utilize latex or latex-containing material to manufacture products. To the best of our knowledge, latex does not come in contact with components or finished good during the manufacturing process. Intended use: Over-the-ear style nasal cannula for delivery of supplemental oxygen to nares of a spontaneously breathing patient. When using oxygen, do use open flame or heat source.