Introducing the Resvent iBreeze Auto CPAP System with Heated Humidification and Wi-Fi compatibility, a feature-rich PAP device that was granted EUA (Emergency Use Authorization) by the FDA in 2020.* Some of the features include IPR (Intelligence Pressure Release), an algorithm during inspiration and expiration offering patients a more comfortable breathing experience; an auto humidifier which adjusts the heat based on room temperature and humidity to prevent rainout in the hose or mask; and finally, a 2-in-1 humidifier design which monitors the water level and when low, will signal a visible alert and automatically switch off the heat to prevent damage to the device. The iBreeze Auto CPAP System comes complete with SD Card, Carry Bag, 6' CPAP Tube, Tube Connector, Power Cord, and User Manual.
This device has been authorized by the FDA for Emergency Use (EUA) during the Coronavirus Disease (COVID-19) pandemic. The FDA definition of the device is a Continuous Ventilator for emergency use that is intended to provide minimal ventilatory support to mechanically control or assist patient breathing during declared public health emergency. The Intended Use of the iBreeze PAP system is to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea (OSA) in spontaneously breathing patients weighing over 30kg (66 lbs.) for use in the home, hospital, or institutional environment.
For more information on the EUA, visit
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/ventilators-and-ventilator-accessories-euas#ventilators
For facts of the known and unknown risks and benefits of the emergency use, visit
https://www.fda.gov/media/136424/download
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MPN |
N/A
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IBREEZE20A-W |
