TECHNICAL DATA SHEET Oxygen Tubing – Clear (9997) SINGLE PATIENT USE | DISPOSABLE Clear, 3-Channel Oxygen Supply Tubing with Female Thread Grip Device Specifications Description Reference Number Operating Temperature SunMed LLC/Salter Labs Storage Temperature Class I Medical Device Internal Diameter Product Code CAE – Airway, Oropharyngeal, Anesthesiology Flow Rate CE Mark / Notified Body Class IIa, Rule 2, EU MDR 2017/745, Annex VIII Female Thread Grip Class II Conformity Assessment Route: MDL Available Tubing Lengths EMDN Code R03010204 Oxygen Administration Tubing GMDN Code 12875 Oxygen Administration, Tubing Product Material UMDNS Code 12875 Tubing, Oxygen Connecting Part Description Polyvinyl Chloride, Clear Patient Population Polyvinyl Chloride Disposable, Single Patient Use Part Number Intended Use: To extend the length of oxygen tubing as accessory to nasal cannulas, oxygen masks and other breathing products. Area of Use: Hospitals, pre-hospital, home, surgical centers, skilled nursing facilities, medical clinics. Contraindications: No known contraindications. Benefits: 3-Channel crush resistant tubing helps to prevent kinking and interruption in flow. No “memory” tubing remains straight when uncoiled. 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. Device Description: Clear, 3-Channel safety oxygen supply tubing with female thread grip connectors used as a conduit to delivery oxygen from the source gas to the patient. 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).