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The BreatheX Nasal Interface System is intended for use as accessory device to CPAP machines in the treatment of obstructive sleep apnea (OSA). The BreatheX Nasal Interface System is for use on adult spontaneously breathing (non-ventilator dependant) patients at home or in the sleep clinic. The BreatheX Nasal Interface System is an accessory intended for use with devices that deliver Continuous Positive Airway Pressure (CPAP) and bi-level positive airway pressure in treating adult patients.

The BreatheX Nasal Interface System has been designed for use as an accessory with commonly marketed CPAP units. The device consists of a plastic manifold with integral exhaust port, nasal mask cushion, a set of nasal pillows, adjustable headgear straps, and an interface tube with a 22mm fitting. The Nasal Interface System allows a patient to use either the nasal pillows or nasal mask cushion interchangeably. The lightweight construction of the device is designed to maximize patient comfort. The device is labeled for single patient use.

The BreatheX Omega continuous positive airway pressure (CPAP) device is intended for use in the treatment of obstructive sleep apnea (OSA). The BreatheX Omega CPAP is used while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA). This is by the delivery of Continuous Positive Airway Pressure (CPAP) at a specified pressure level in order to prevent airway obstruction. The BreatheX Omega CPAP is for use on adult patients weighing at least 30 kg, spontaneously breathing (non-ventilator dependant) patients at home or in the sleep clinic. The BreatheX Omega is not intended for life support. The BreatheX Omega CPAP device is intended for treatment of obstructive sleep apnea (OSA) in spontaneously breathing adults weighing at least 30 kg. The BreatheX Omega CPAP device provides continuous positive airway pressure. Caution: Federal law restricts this device to sale by or on the order of a physician.

The BreatheX provides a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. The device is battery operated. The BreatheX Omega is comprised of a motorized blower assembly that provides positive air pressure. The blower speed is directly related to air pressure, and is controlled by software. The BreatheX Omega CPAP device consists of the following main components: - CPAP blower . - Battery/Battery charger . - Therapy Tubing . The patient interface (CPAP mask) is a commercially available accessory provided separately. The patient interface is not covered in this submission.