FDA.reportPublic FDA data

Bridge to Life Ltd

Matched from indexed company URL: Bridge TO Life, Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30318848333031884833Bridge to Life Ltd1Y2026-01-013300 Breckinridge Blvd Ste 200 Duluth GA US 30096
30091100223009110022BRIDGE TO LIFE LTD.1Y2020-04-25128 Suber Rd. Suite A Columbia SC US 29210

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00198715358155Belzer UW Cold Storage Solution - For flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient. 1000mL(803) 545-0080orders@B2LL.com
00199284210417Belzer UW Cold Storage Solution - For flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient. 2000mL(803) 545-0080orders@B2LL.com
00199284309944Belzer UW Cold Storage Solution - For flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient. 1000mL(803) 545-0080orders@B2LL.com
00199284432970VitaSmart Hypothermic Oxygenated Perfusion System - 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.(803) 545-0080orders@B2LL.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3440491695881836K243840Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)KDN2025-03-26
3440492044759741K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)KDN2025-06-17
3440491351106049K243384Belzer UW® Cold Storage Solution (BTLBUW-001)KDN2025-03-31
3440491463420080K203262Cannula for Organ PerfusionKDN2021-07-01
3440491357970833K191006EasiSlushKDN2019-09-24
3440491313827321DEN250009VitaSmart Hypothermic Oxygenated Perfusion SystemSGY2026-01-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KDN52025-06-17
SGY12026-01-15

PMN#

GUDID#

VitaSmart Hypothermic Oxygenated Perfusion System-VitaSmart Liver Perfusion Kit - 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.

2026-02-20

VitaSmart Hypothermic Oxygenated Perfusion System - 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.

2026-02-20