VitaSmart Hypothermic Oxygenated Perfusion System-VitaSmart Liver Perfusion Kit

GUDID 00199284522503

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.

Bridge To Life Ltd.

Electric infusion pump administration set, single-use

• Primary Device ID: 00199284522503
• NIH Device Record Key: bf7be3d8-c0c5-4e0f-920d-1fc63eb36045
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitaSmart Hypothermic Oxygenated Perfusion System-VitaSmart Liver Perfusion Kit
• Version Model Number: VS03LIVER
• Company DUNS: 830330457
• Company Name: Bridge To Life Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com
• Phone: (803) 545-0080
• Email: orders@B2LL.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199284522503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN250009

FDA Product Code

• SGY: Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-02
• Device Publish Date: 2026-02-20

Devices Manufactured by Bridge To Life Ltd.

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• 00199284522503 - VitaSmart Hypothermic Oxygenated Perfusion System-VitaSmart Liver Perfusion Kit: 2026-03-02The 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.
• 00199284522503 - VitaSmart Hypothermic Oxygenated Perfusion System-VitaSmart Liver Perfusion Kit: 2026-03-02 The VitaSmart Hypothermic Oxygenated Perfusion System (VitaSmart HOPE System; VitaSmart System) is intended to be used for the h
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