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A-Model: The F&P Nova Micro Pillows Mask is intended to be used by adults weighing ≥ 66 lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or bi-level by a physician. The F&P Nova Micro Pillows Mask is intended for single-patient use in the home. SLA-Model: The F&P Nova Micro Pillows Mask is intended to be used by adults weighing ≥ 66 lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or bi-level by a physician. The F&P Nova Micro Pillows Mask is intended for single-patient use in the home and for multiple-patient use in the hospital or other clinical settings where proper disinfection of the device can occur between patient uses.

The F&P Nova Micro Pillows Mask is a non-invasive, Positive Airway Pressure (PAP) therapy nasal pillows mask with a silicone seal that seals the nasal airway entrance of the Nova Micro Pillows Mask is designed to aid in the delivery of PAP by providing an interface between the flow generator and tubing, and the patient. The Nova Micro Pillows Mask features a pillows cushion with prongs that extrance of the patient's nasal nares, held in place by adjustable headgear straps. The Nova Micro Pillows Mask is a prescription-only device, provided in a non- sterile state. The F&P Nova Micro Pillows Maskrange is available in three cushion sizes – Small, Medium, and Large. The mask has two models: A-Model and Sleeplab (SL) A-Models are identical except for their Indications for Use, Operating Environment, and Reusability. The A-Model is intended to be single-patient use in the home, while the SL A-Model is intended to be used on multiple patients in a hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

The Fisher & Paykel Healthcare single patient use masks are intended for use as an accessory to ventilators to enable noninvasive positive pressure ventilation (NPV) therapy (CPAP or bi-level) to be delivered to spontaneously breathing adult patients (>30kg) with respiratory insufficiency or respiratory failure who have been prescribed NPPV. The masks are to be fitted and therapy maintained by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.

The Nivairo™ RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version (herein referred to as RT046) is a non-vented hospital full face mask with a standard elbow for use with dual limb circuits. The RT046 is a single use device intended for use as an accessory to deliver non-invasive positive pressure ventilation (NPPV) to a patient as part of a passively vented non-invasive ventilation system. The RT046 is an oronasal full face mask intended to be used in a hospital/institutional environment by trained medical staff with patient monitoring systems in place. It connects to a dual limb breathing circuit via a 22mm female swivel adaptor to receive pressurized breathing gases from an external flow source or ventilator (CPAP or Bi-Level). The RT046 mask is a prescription only device, provided in a non-sterile state.

The Fisher & Paykel Healthcare single patient use masks are intended for use as an accessory to ventilators to enable noninvasive positive pressure ventilation (NPPV) therapy (CPAP or bi-level) to be delivered to spontaneously breathing adult patients (>30 kg) with respiratory insufficiency or respiratory failure who have been prescribed NPPV. The masks are to be fitted and therapy maintained by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.

The Nivairo™ RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve (herein referred to as RT045) is a non-vented hospital full face mask with anti-asphyxiation valve for use with single limb circuits. The RT045 is a single use device intended to deliver noninvasive positive pressure ventilation (NPPV) to a patient as part of a passively vented noninvasive ventilation system. The RT045 is an oronasal full face mask intended to be used in a hospital/institutional environment by trained medical staff with patient monitoring systems in place. It connects to a single limb breathing circuit via a 22mm female swivel adaptor to receive pressurized breathing gases from an external flow source or ventilator (CPAP or Bi-Level). The RT045 mask is a prescription only device, provided in a non-sterile state.