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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E
FDA Enforcement
Class II
·Ongoing·Mc3 Inc·March 27, 2024
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E
FDA Enforcement
Class II
·Ongoing·Mc3 Inc·March 27, 2024