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The Breathe Technologies Life2000™ Ventilation System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The Life2000 Ventilation System consists of the Life2000 Ventilator and the Life2000 Compressor. The System is intended for use by qualified, trained personnel under the direction of a physician. Specifically, the System is applicable for adult patients who require the following types of ventilatory support: - · Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). - · Assist/Control mode of ventilation. The System is suitable for use in home and institutional settings and is not intended for ambulance or air transportation.

The Breathe Technologies Life2000 Ventilation System includes a portable, battery powered, continuous ventilator that was cleared in K141943 along with the Breathe Pillows Interface, Universal Connector and various other dedicated accessories. In this submission, the Life2000 Ventilation System is expanding with the inclusion of additional components, including the Life2000 Compressor, a portable air compressor. This Life2000 Compressor provides a primary source of compressed air for the Life2000 Ventilator, in addition to the previously cleared gas sources of facility in-wall compressed gas (air & oxygen) and tanks of compressed medical gas. The Life2000 Compressor provides a dedicated docking station for the Life2000 Ventilator. The Ventilator administers the physician-prescribed volume to the patient via the previously cleared Breathe Technologies Universal Connector which connects into the patient's tracheostomy tube, endotracheal tube, or any off the shelf non-invasive mask. It can also be used with the previously cleared Breathe Technologies Pillows Interface (K141943), a type of nasal mask. This submission includes new versions of the Pillows Interface, labeled as the Breathe Pillows Entrainment Interface, that have an inlet for supplemental oxygen. It also includes labeling for the use of third party supplemental Oxygen Adapters for use with the Universal Connector. These inlets or Adapters allow the physician to administer supplemental oxygen into the patient circuit or interface.

The Breathe Technologies Life2000 Ventilation System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult patients who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). - Assist/Control mode of ventilation. The ventilator is suitable for use in home and institutional settings.

The Breathe Technologies Life2000 Ventilation System is a portable, battery powered, critical care ventilator. The Ventilator administers the physician-prescribed volume to the patient via the attached Breathe Technologies Patient Universal Connector which connects into the patient's tracheostomy tube, endotracheal tube, or any off the shelf non-invasive mask. It can also be used with the Breath Technologies NIOV Pillows Interface, a type of nasal mask. The ventilator is small and light enough to be worn on a patient's belt, or slung over their shoulder. It is connected to a separate, third party, gas supply. The Ventilator is intended for Institutional or Home Use. It is not intended for use during emergency/medical transportation.

The NIOV Ventilator, with accessories; is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients that are capable of spontaneously breathing a minimum tidel volume of 3.5 ml/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or their caregivers under the direction of a physician.

The Breathe Technologies NIOV Ventilator System is a battery powered, wearable, volume ventilator that augments the patient's spontaneous breathing. The NIOV Ventilator administers this physician-prescribed volume to the patient via the attached Breathe Technologies Patient Circuit (BT-PC) which inserts into the patient's tracheostomy tube, or via the Breath Technologies NIOV Pillows Interface, a type of nasal mask. The ventilator is small and light enough to be worn on a patient's belt, or slung over their shoulder. It is connected to a separate, third party, air or oxygen gas supply. The Ventilator is cleared for Institutional or Home Use.

The continuous positive airway pressure (CPAP) System is indicated for the treatment of obstructive sleep apnea (OSA) in patients > 661b (30 kg). The Breathe CPAP System is intended for single-patient re-use in the home environment.

The Breathe Technologies™ CPAP system is an AC powered Continuous Positive Airway Pressure (CPAP) device that delivers a physician prescribed pressure during the inspiratory phase and expiratory phases to help maintain airway patency during sleep for patients with obstructive sleep apnea (OSA). The Breathe CPAP System consists of a programmable, microprocessor controlled, flow generator (i.e., blower) and a Nasal Pillows Mask. The flow generator generates CPAP from room air to the patient and transmits it via the attached Nasal Pillows Mask. The end of the patient circuit is a nasal pillows interface which is worn on the nose. The nasal interface is held in place with standard headgear.

The Breathe Technologies™ Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients, or caregivers under the direction of a physician.

The Breathe Technologies Ventilator with Accessories (BT-V2S) is a small, wearable, ventilator that interfaces with proprietary nasal and tracheostomy breathing circuits.

The Breathe Technologies Ventilator (BT-V2S), with Accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients, with or without a tracheostomy, that are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional environment. The device is intended for operation by trained personnel under the direction of a physician.

This application is being filed to allow a new breathing circuit for the Breathe Technologies Ventilator (BT-V2). The Ventilator is fundamentally unchanged. The only difference between the predicate and application submissions is that the application requests clearance to market the BT-NT nasal interface with the BT-V2S ventilator. The BT-NT is a nasal mask style patient circuit which attaches to the patients nose. It connects to the BT-V2S ventilator. The BT-NT is approximately 12cm wide and 2cm thick at its thickest point under the patient's nose. These dimensions do not include the 231 cm dual tubing that connects to the Ventilator. It is composed of various plastics.

The Breathe Technologies™ Ventilator BT-V2S, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory in u vouln'is assist patients with a tracheostomy that are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occurational therapy, respiratory therapy, and other rehabilitation efforts in an institutional environment. The device is intended for operation by trained personnel under the direction of a plysician

The Breathe Technologies™ Ventilator (BT-V2S) is a battery powered (which may be charged during use) wearable, volume ventilator that augments the patient's spontaneous breathing. The BT-V2S administers this physician-prescribed volume to the patient via the attached Breathe Technologies Patient Circuit (BT-PC). The end of the BT-PC is inserted into the patient's tracheostomy tube. The ventilator is small and light enough to be worn on a patient's belt, or slung over their shoulder.

The Breathe Technologies™ Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients with a tracheostomy that are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional environment. The device is intended for operation by trained personnel under the direction of a physician.

The Breathe Technologies™ Ventilator (BT-V) is a battery powered, wearable, volume ventilator that augments the patient's spontaneous breathing. The BT-V administers this physician-prescribed volume to the patient via the attached Breathe Technologies Transtracheal Tube (BT-TT). The end of the BT-TT is inserted into the patient's tracheostomy tube. The ventilator is small and light enough to be worn on a patient's belt, or slung over their shoulder, because it has only a subset of the features of a full-featured ventilator.