High Concentration, Non-Rebreather Oxygen Mask – Pediatric
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TECHNICAL DATA SHEET High Concentration, Non-Rebreather Oxygen Mask – Pediatric LATEX FREE | SINGLE PATIENT USE | DISPOSABLE High Concentration, Non-Rebreather Oxygen Mask with Safety Vent, Pediatric Reference Number SunMed LLC/Salter Labs Class I Exempt, Medical Device BYG-Oxygen Mask Canadian Medical Device Class II Conformity Assessment Route: MDL Class IIa, Rule 2, EU MDR 2017/745, Annex VIII CE Mark/ Notified Body CE 2797, Global- BSI Group (Global) EMDN Code GMDN Code 35172, Aerosol Face Mask, Non-Rebreathing UMDNS Code 12449, Masks, Air-Oxygen, Aerosol Administration Disposable, Single Patient Use Patient Population Device Specifications Description Flow Rate ≥ 10 LPM, Adjust flow to keep bag 1/3 full during inspiration Operating Temperature Storage Temperature Tubing Length Ribbed, Universal Push-On Product Material Part Description Polyvinyl Chloride Polyvinyl Chloride Polyvinyl Chloride Polypropylene Aluminum Elastic Cloth Silicone, Clear Polyvinyl Chloride Intended use: To provide supplemental oxygen to a spontaneously breathing patient. Part Number Area of use: Hospitals, pre-hospital, home, surgical centers, skilled nursing facilities, medical clinics. Contraindications: No known contraindications. Benefits: Provide supplemental oxygen to help treat hypoxia, relieve shortness of breath, and pre-oxygenate a patient. 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 NonDEHP; 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). Description: A clear mask connected a reservoir bag and oxygen supply tubing. The mask is placed over a patient’s nose and mouth and held in pace with an elastic fixation device. The non-rebreather mask has a one-way valve above the reservoir bag to prevent the patient from rebreathing previously exhaled gases and a one-way valve over one of the exhalation ports on the mask