6515--Vitaflow Capital Bundle w/ Cart Brand Name or Equal

The West Haven VA Medical Center is seeking to purchase a Vitaflow Capital Bundle w/ Cart, which is an Extracorporeal Membrane Oxygenation (ECMO) system. The system is designed to provide cardiopulmonary support for critically ill adults. The solicitation is set aside for small businesses, and the associated NAICS code is 339112. The vendor must provide comprehensive education and hands-on training on the offered ECMO system for VA hospital clinical staff. The system must meet or exceed the salient characteristics listed in the solicitation, including FDA clearance, system configuration, and mobility/cart configuration. • The system must be capable of providing continuous ECMO support up to 48 hours. • The system must be designed for adult patients with acute respiratory failure or acute cardiopulmonary failure. • The system must include a console, centrifugal blood pump, membrane oxygenator, backup/emergency manual drive mechanism, and mobile transport cart. • The vendor must provide clinical education and hands-on training for VA hospital clinical staff. • The system must comply with applicable VA medical device cybersecurity requirements.