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The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in the hospital, clinic or home environments. The Nasal-Aire II Pediatric is intended for single-patient re-use in the home environment and multiple-patient re-use in the hospital / institutional environment.

The Nasal-Aire II Pediatric has been modified from the Nasal-Aire II to meet the requirements of the pediatric population and adults requiring smaller sizes to achieve the proper fit and comfort. The Nasal-Aire II Pediatric provides therapy through the nose only. The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in hospital, clinic, or home environments. For homecare applications, the Nasal-Aire II Pediatric may be reused multiple times by a single patient. For institutional applications (i.e. sleep lab, other clinical settings), the interface may be reused multiple times by multiple patients. The Nasal-Aire II Pediatric interface has a soft nasal cannula to form a seal with the nasal openings. The nasal cannula has two nasal inserts and has integrated exhalation ports. The interface also has tubing, connectors to attach the tubing to the nasal cannula, and a swivel coupling that allows the interface to connect to the ventilation device. Headgear is attached to the device to secure the interface on the patient. There are five nasal cannula sizes available, ranging from A (largest) to E (smallest). The device is available by prescription only.

The Hybrid NE Mask is 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. (Applies to the standard version): For homecare applications, the Hybrid NE Mask may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients. (Applies to the Disposable version): The RespCare Hybrid NE Mask Disposable is a single patient, single use interface.

A specialized interface for Non-Invasive Ventilation. It will be modeled after the RespCare Face Mask (K052227), with intentional exhalation features removed for use with ventilators equipped with an active safety valve.

The RespCare Hybrid AV Mask is intended for use by adults (> 30 kg) as a patient interface for CPAP or Bi-Level positive-pressure ventilation devices for treatment of respiratory insufficiencies and obstructive sleep apnea. (Applies to the standard version): For homecare applications, the Hybrid AV Mask may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients. (Applies to the Disposable version): The Hybrid AV Disposable Mask is a single patient, single use interface.

The RespCare Hybrid AV Mask is a patient interface accessory to a positive pressure ventilator intended for treatment of respiratory insufficiencies and obstructive sleep apnea. The device delivers positive airway pressure from a CPAP or bi-level device to the patient's oral and nasal passages. Connection to the ventilator device is made by a standard 22 mm fitting. The mask is held in place on the face by headgear worn around the head. The device includes anti-asphyxia valve and oxygen entrainment port features.

The Utopia is intended for use by adults (> 30 kg) as a patient interface for currently-marketed CPAP or Bi-Level positive-pressure ventilation devices for treatment of respiratory insufficiencies and obstructive sleep apnea. (Applies to the standard version): For homecare applications, the Utopia may be reused multiple times by a single patient. For non-homecare applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients. (Applies to the Disposable version): The Utopia Disposable is a single patient, single use interface.

The Utopia is a patient interface accessory to a positive pressure ventilator intended for treatment of respiratory insufficiencies and obstructive sleep apnea. The device delivers positive airway pressure from a CPAP or bi-level device to the patient's oral and nasal passages. Connection to the ventilator device is made by a standard 22 mm fitting. The mask is held in place on the face by a forehead pad and headgear worn around the head. The device includes exhalation port. anti-asphyxia valve, and oxygen entrainment port features.