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VitaSmart Hypothermic Oxygenated Perfusion System

Bridge To Life Ltd. · Model V0001-US · UDI-DI 00199284432970

SGY Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The VitaSmart Hypothermic Oxygenated Perfusion System (VitaSmart HOPE System; VitaSmart System) is intended to be used for the hypothermic oxygenated perfusion of livers (via the portal vein) for preservation and transplantation into a receiving patient. The VitaSmart HOPE System is intended to be used by healthcare professionals within a professional healthcare facility and is not intended to be used in transport. The VitaSmart System is comprised of two primary components: the reusable Base Unit (consisting of system electronics, pump control, perfusion sensors, user interface, and portable stand or trolley), and the disposable Perfusion Kit (consisting of tubing set, oxygenator, RFID tag, arterial filter). The VitaSmart HOPE System pumps oxygenated perfusion solution through the connected disposable Perfusion Kit that is connected to the organ (liver) with the Base Unit controlling and monitoring via the pump control and perfusion sensors. Alarms have been developed to communicate with the user and ensure that proper perfusion is occurring.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.