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

Combined Synopsis-Solicitation for Commercial Products and Commercial Services Effective Date: 01/15/2026 Revision: 03 Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format Revolutionary FAR Overhaul (RFO) in Federal Acquisition Regulation (FAR) subpart 12.202, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01. This solicitation is set aside for Small-Business The associated North American Industrial Classification System (NAICS) code for this procurement is 339112, with a small business size standard of 1,000 Employees The FSC/PSC is 6515. The West Haven VA Medical Center 950 Campbell Avenue West Haven VA, CT 06516 2770 is seeking to purchase the following items from below. The West Haven VA Medical Center is seeking (1) Vitaflow Capital Bundle w/ Cart Brand Name Medtronic or Equal. This is a new brand name or equal requirement. All interested companies shall provide quotations for the following: Supplies/Services Line Item Description Quantity Unit of Measure VITALFLOW CAPITAL BUNDLE WITH CART INCLUDES: 1 EA 58100 VITAL FLOW CONSOLE(INCLUDES FLOW & BUBBLE SENSOR, POWER CORD) 1 EA 58102 58102 MOTOR DRIVE & HOLDER; 1 EA 58103 58103-EMERGENCY HANDCRANK; 1 EA 58130 58130-OXYGENATOR DATA CABLE 1 EA 58120 58120-VITALFLOW TRAVEL CADDY 1 EA ECM-9688-1 VITALFLOW CART 1 EA DELIVERY LOCATION: West Haven VA Medical Center Jamaica Plain VA Medical Center 950 Campbell Avenue West Haven VA, CT 06516 2770 FOB: Destination Statement of Work West Haven VA Medical Center ECMO System Statement of Work  1. General Information The Extracorporeal Membrane Oxygenation (ECMO) system requested under this Statement of Work is an advanced life support platform that temporarily takes over the function of a patient's heart and lungs. It is designed to provide cardiopulmonary support for critically ill adults facing acute, life-threatening respiratory or cardiac failure. This is a brand name or equal requirement. The Medtronic VitalFlow ECMO system is cited as representative of the salient characteristics required (see Section 5, Equipment Specifications/Salient Characteristics). Any product offered as an equal must meet or exceed all salient characteristics listed. This is not a sole-source or brand-name-only requirement.  2. Background The Surgical Department at the West Haven VA Medical Center (VA Connecticut Healthcare System) has identified a need for an ECMO system to support cardiopulmonary care for critically ill Veterans. Any offered system, including VitalFlow or an equal, will be evaluated against the salient characteristics in Section 5.  3. General Requirements The Vendor shall be capable of delivering the entire required quantity of units to all designated sites within the required time frames. Vendor shall ensure compliance with all applicable laws concerning construction, packaging, labeling, registration, and transportation of the equipment. The Vendor shall not make unannounced alterations to the design or components of delivered equipment without prior notification and written approval by the Contracting Officer's Representative (COR). The Vendor shall deliver all units within 60 days of contract award.  4. Regulatory and Compliance Requirements The offered system, whether VitalFlow or an equal, shall hold current FDA clearance/approval (e.g., 510(k) or PMA, as applicable) for its intended use in adult cardiopulmonary life support. The offered system shall comply with applicable VA medical device cybersecurity requirements, including VA Handbook 6500 and Medical Device Isolation Architecture (MDIA) requirements, where applicable.  5. Equipment Specifications / Salient Characteristics To be considered an acceptable "equal" product, an offered ECMO system must meet or exceed the following salient characteristics. Characteristic Required Specification 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 Indicated patient population Adult patients with acute respiratory failure or acute cardiopulmonary failure, where other treatment options have failed System configuration Complete system including console, centrifugal blood pump, membrane oxygenator, backup/emergency manual drive mechanis