EUA | 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.——iBreeze PAP EUA-Notice
Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories
iBreeze PAP model(s) include iBreeze 20A APAP machine.
Proprietary Name: iBreeze PAP(iBreeze 20A; iBreeze 25ST; iBreeze 25STA)
Designated Medical Devices Listed by Canada
iBreeze CPAP System (model 20A) / iBreeze 20A APAP machine is eligible for the exceptional importation and sale provisions provided for in the Interim Order.
Medical Device: iBreeze CPAP System (model 20A); MDEL: 19863
CE
The device should only be purchased and used in accordance with local laws and regulations.
Source: EC Certificate
Manufacturer: Resvent Medical Technology Co., Ltd.