TECHNICAL DATA SHEET 8961 NebuTech® High Performance Nebulizer LATEX FREE | SINGLE PATIENT USE | DISPOSABLE NebuTech Disposable Nebulizer Without Tubing Reference Number SunMed | Salter Labs FDA Class II Medical Device, K014056 Class IIa, Rule 20-Noninvasive Devices, MDR 2017/745 Classification – Canada Class II Canadian Medical Device Regulations Product Code EMDN Code R060101 Cold Nebulizing System GMDN Code 35457, Nebulizing System, Non-Heated UMDNS Code Disposable, Single Patient Multiple Use Patient Population Infant, Pediatric and Adults Individually Packaged, 50 Case Intended use: A hand-held pneumatically powered nebulizer that consists of reservoir tower screwed onto a medication cup. The gas supply tubing connects to a fitting at the bottom of the cup. The valved reservoir chamber and valved mouthpiece enhance medication delivery. Package includes nebulizer and valved mouthpiece. Indication for use: To administer prescribed aerosolized medication to spontaneously breathing patients. Patient population includes infant, pediatric and adult patients. Benefit: The high-performance nebulizer is designed for faster delivery time, more efficient aerosol delivery system and less medication waste. The aerosol mask provides an option for oral and nasal medication delivery. Anti-drool feature prevents secretions from draining back into nebulizer cup. Reservoir provides large bolus of medication on first part on inhalation. Warning: • This product is disposable and is not intended for prolonged or extended use. • Device contains components that may present choking hazard. • To avoid risk of infection and contamination follow instruction for use for cleaning and maintenance of the nebulizer. • If using oxygen, do not use near flame or heat source. Area of use: Hospitals, sub-acute, medical clinics, pre-hospital, home, and other medical facilities. Duration of use: Replace the nebulizer every 7 days, or sooner if it becomes damaged, contaminated or is not functioning properly. Contraindications: None known.

TECHNICAL DATA SHEET 8961 NebuTech® High Performance Nebulizer Device Specifications NebuTech Nebulizer Product Material Part Description Gas Flow Rate Minimum Polypropylene, Opaque White Gas Flow Rate Maximum Cone (Insert) Polystyrene, Transparent Green Reservoir Tower Capacity One-Way Valve High Density Polyethylene Minimum Fill Volume Flutter Valve Maximum Fill Volume High Density Polyethylene, White Mouthpiece Outlet Mouthpiece Feature One-Way Exhalation Valve, Anti-Drool Feature Nebulization Angle 45° Angle to Vertical Position Operating Temperature Storage Temperature Latex: SunMed® does...