Vitaflow Capital Bundle w/ Cart Brand Name or Equal RFP

Description: To be considered an acceptable "equal" product, an offered ECMO system must meet or exceed the following salient characteristics. FDA clearance / regulatory classification: Class II device cleared under 21 CFR 870.4100 (Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure), or equivalent product code classification (e.g., QNR for pump/console, BYS for oxygenator). Indicated duration of use: Indicated for continuous ECMO support up to 48 hours. See attached file.