Authorized By FDA and EUA
EUA (Emergency Use Authorization) by FDA
"FDA has determined that the iBreeze PAP model(s) meet the criteria for
safety, performance and labeling set forth in Section II and Appendix A
of the EUA."
Source: Resvent-iBreeze PAP EUA-Notice
Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories
Manufacturer: Resvent; Product Name: iBreeze PAP
Source: Ventilators and Ventilator Accessories EUAs
* iBreeze PAP
(iBreeze 20A) has been authorized by FDA under an EUA.
Designated medical devices listed by Canada
iBreeze CPAP System (model 20A) manufactured by Resvent Medical
Technology Co., Ltd. is authorized by Health Canada under Exceptional
Medical Device: iBreeze CPAP System (model 20A); MDEL: 19863
Source: List of Medical Devices for Exceptional Importation and Sale
Source: EC Certificate
The device should only be purchased and used in accordance with local laws and regulations.
Manufacturer: Resvent Medical Technology Co., Ltd.