3 results
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10ms
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Sources: EU EUDAMED, US FDA
Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed,
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code QJZ·December 7, 2021
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure Product Code: F30000163
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code QJZ·April 8, 2024
EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband light source emitting incoherent non-laser light from the Deep UV through the visible wavelengths.
FDA Recall
Open, Classified
·Energetiq Technology Inc·Product code REK·September 27, 2019