High Concentration, Non-Rebreather Oxygen Mask – Pediatric

Product catalog summary

Product Overview
The High Concentration, Non-Rebreather Oxygen Mask with Safety Vent is designed for pediatric use. It is manufactured by SunMed LLC/Salter Labs and classified as a Class I Exempt medical device by the FDA. The mask is intended for single patient use and is non-sterile. It is made in Mexico and packaged individually with 50 units per case.

Intended Use and Benefits
This device is used to provide supplemental oxygen to spontaneously breathing patients, particularly in settings such as hospitals, pre-hospital environments, homes, surgical centers, skilled nursing facilities, and medical clinics. It helps treat hypoxia, relieve shortness of breath, and pre-oxygenate patients. There are no known contraindications.

Device Specifications

Flow Rate: ≥ 10 LPM, with the bag kept 1/3 full during inspiration.
Oxygen Concentration: Variable from 60% to 90%.
Operating Temperature: 6°C to 40°C.
Storage Temperature: -40°C to 60°C.
Tubing: 3-Channel Safety, 7 feet (2.1 meters) in length.
End Connector: Ribbed, Universal Push-On.

Materials

Tubing, Mask, Reservoir Bag: Polyvinyl Chloride.
End Connector: Polyvinyl Chloride.
Grommet: Polypropylene.
Nose Bar: Aluminum.
Strap: Elastic Cloth.
Valve: Silicone, Clear.

Safety and Compliance
The product is latex-free, non-DEHP, and does not contain lead or mercury. It is biocompatible according to ISO 10993 standards and manufactured in compliance with Good Manufacturing Practices (GMPs) as per 21 C.F.R.

Catalog excerpts

High Concentration, Non-Rebreather Oxygen Mask – Pediatric-1

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

Open the catalog to page 1