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The Sleepnet Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O. The masks are to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. Mojo is intended for Single patient, multi-use in the home or hospital/institutional environment. Veraseal 2 is intended for Short Term Single Patient use (maximum of 7 days) in the hospital institutional environment. Innova is intended for Single patient, multi-use in the home or hospital/institutional environment. Ascend is intended for Single patient, multi-use in the home or hospital/institutional environment.

The Sleepnet Mojo Vented Full Face Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are used with positive pressure devices, such as CPAP and Bi-level. The modifications to the cleared Mojo Full Face mask (K120463) are: - Addition of contraindication and updated warning related to presence of magnets - Change to the headgear material - Addition of an XL size The modifications to the cleared Veraseal Full Face mask (K120463) are: - Modified design, now called the Veraseal 2 Full Face Vented Mask - . Addition of an XL size Other modifications include: - Addition of the Innova Full Face Vented Mask version - Addition of the Ascend Full Face Vented Mask version

The Sleepnet Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, and V3 Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H2O. The masks are to be used on adult patients (>30 kg.) for whom positive airway pressure therapy has been prescribed. Veraseal 3 -Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional) V3 -Single patient, multi-use (home) Mojo 2 -Single patient, multi-use (home or hospital/institutional)

The Sleepnet Veraseal 3, V3 and Mojo 2 Full Face Vented masks are identical to the predicate Veraseal 3, V3, and Mojo 2 Full Face Vented masks (K190254). The subject of this submission is: - Addition of a contraindication related to magnets on the Mojo 2 Full Face Vented mask . - . Update to the warning related to magnets on the Mojo 2 Full Face Vented mask

The Sleepnet Mojo 2 and Veraseal 3 Full Face Non-Vented and AAV Non-Vented Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multi-use version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation. Veraseal 3 - Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional) Mojo 2 -Single patient, multi-use (home or hospital/institutional)

The Sleepnet Mojo 2 and Veraseal 3 are full face mask used with non0invasive ventilation. They are available in multiple sizes and in a Non-Vented style with an elbow and Non-Vented with elbow and anti-asphyxia (AAV) valve. The subject of this submission is: - The Mojo 2 subject devices include a new contradiction and warning, which was not . included in the predicate device - K190533. Veraseal 3 is intended as a Disposable single use (hospital/institutional) and as a Single patient, multi-use up to 7 days (hospital/institutional) Mojo 2 is intended as a Single patient, multi-use (home or hospital/institutional)

The iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at 3 cmH2O to 30 cmH2O. The masks are to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The masks are intended for single-patient multi-use in the home, hospital or institutional environment.

The Sleepnet iQ 2 and Phantom 2 Nasal Vented masks are nearly identical to the Predicate Sleepnet iQ 2 and Phantom 2 Nasal Mask (K211274). The subject of this submission is: Addition of a contraindication related to magnets on the iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask; Update to the warning related to magnets on the iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask. Device provides a seal over the nose to allow for delivery of pressurized air from a positive airway pressure device. Device has an exhalation port for flushing out exhaled CO2. The device is passive until connected to the positive pressure device.

The iQ 2 and Phantom 2 Nasal Mask is intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O to 30 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital or institutional environment.

The Sleepnet iQ 2 and Phantom 2 Nasal masks are patient interfaces for use with positive pressure equipment, i.e., CPAP and bi-level. They incorporate an exhaust port in the shell. The 2 styles are similar: Same patient population and Indications for Use, Same headgear, Same headgear connector components, Same tubing assembly, Same materials and manufacturing processes. They differ only in: Mask shell shape, Gel cushion shape.

The Innova™ Nasal Non-Vented Mask is intended to be used as an accessory to CPAP/bi-level positive pressure systems containing exhalation valves. This product is indicated for use with CPAP/BI-LEVEL systems that have adequate alarins for positive pressure delivery failure. The mask is ingle patient, multi-use in the home, hospital or institutional environment on adult patients (>30kg/66 lbs.).

The Sleepnet Innova™ Non-Vented Nasal mask is a patient interface for use with positive pressure equipment. There are 2 labeled versions: - Single patient, multi-use (home or hospital/institutional) up to 6 months . - Single patient, multi-use up to 7 days (hospital/institutional) .

The Sleepnet Moio 2 and Veraseal 3 Non-Vented and AAV Non-Vented Full Face Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation. Veraseal 3 - Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional) Mojo 2 - Single patient, multi-use (home or hospital/institutional)

The Sleepnet Mojo 2 and Veraseal 3 are full face mask used with non0invasive ventilation. They are available in multiple sizes and in a Non-Vented style with an elbow and Non-Vented with elbow and anti-asphyxia (AAV) valve. The subject of this submission is: - . Slight redesign of the shape of the masks but no appreciable differences as the elbow is identical to the predicate - Add an anti-asphyxia valve (AAV) option . - Add an additional size, ex-large, mask to the product line ● Veraseal 3 is intended as a Disposable single use (hospital/institutional) and as a Single patient, multi-use up to 7 days (hospital/institutional) Mojo 2 is intended as a Single patient, multi-use (home or hospital/institutional)

The Sleepnet Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, and V3 Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H₂O. The masks are to be used on adult patients (>30 kg.) for whom positive airway pressure therapy has been prescribed. Veraseal 3: Disposable single use (hospital/institutional), Single patient, multi-use up to 7 days (hospital/institutional) V3: Single patient, multi-use (home) Mojo 2: Single patient, multi-use (home or hospital/institutional)

The Sleepnet Mojo 2, Veraseal 3 and V3 Full Face mask are provided with an exhalation elbow and anti-asphyxia (AAV) valve. The subject of this submission is: - Slight redesign of the shape of the masks but no appreciable differences as the identical exhalation elbow and anti-asphyxia valve (AAV) - Add an additional size, ex-large, mask to the product line - Support useful life of the V3 and Mojo 2 up to 6 months as a single patient, multi-use mask Veraseal 3 is intended as a Disposable single use (hospital/institutional) and as a Single patient, multi-use up to 7 days (hospital/institutional) V3 is intended as a Single patient, multi-use (home) Mojo 2 is intended as a Single patient, multi-use (home or hospital/institutional

The Hard Shell Vented Nasal Mask is intended to provide an interface for application of positive airway pressure therapy, such as CPAP or bi-level. The mask is intended for: - Single use, disposable . - . Single patient, multi-use in the home setting - . Multi-patient, multi- use in the hospital or institutional settings - Single patient, short-term use (up to 7 days) in the hospital or institutional settings ● The masks are to be used on adult patients (>66 lbs. />30 kg) for whom CPAP or bi-level therapy has been prescribed.

The SleepNet Innova Nasal Vented Mask is similar to other CPAP mask. The Innova Nasal Vented mask is nearly identical to our iQ Nasal mask, K102317, except for the following changes: - Slightly different indications for use, but the predicate is Respironics ComfortGel Blue . Nasal mask, K092835. - . A range of durations of use for marketing purposes only - o single use, disposable - single patient, multi-use up to 7 days o - single patient, multi-use in home setting o - o multi-patent, multi-use in institutional settings - . material for shell, hard vs. soft - a new exhaust elbow design .