Tag: Life2000

DEERFIELD, Ill. – Baxter International has issued an urgent medical device correction for the Life2000 ventilation system due to the potential for patient oxygen desaturation (low blood oxygen) events that may occur under certain conditions when the system is connected with a third-party oxygen concentrator. Low oxygen saturation may lead to symptoms like shortness of breath, confusion, rapid heart rate or bluish skin. Among the most vulnerable patients, death, life-threatening events or permanent...

IRVINE, Calif. - Breathe Technologies will significantly extend its reach into the vent market on Jan. 1 when it plans to launch Life2000.The system received 510(k) clearance from the Food and Drug Administration in June and Medicare coverage for invasive and non-invasive ventilators in September. Breathe Technologies' first product, the Non-Invasive Open Ventilation or NIOV system, has broken down barriers as an ultra-lightweight device but only has Medicare coverage under E1352, oxygen accessory,...