VitaSmart Hypothermic Oxygenated Perfusion System

• K Number: DEN250009
• Device Name: VitaSmart Hypothermic Oxygenated Perfusion System
• Manufacturer: Bridge TO Life, Ltd.
• Date Cleared: 2026-01-15 ( 290 days)
• Product Code: SGY
• Regulation Number: N/A
• Type: Direct
• Panel: Gastroenterology/Urology
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

N/A