Bridge to Life Ltd

FDA Device Registration & Listing · Duluth, GA, US · Registration 3031884833

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3031884833
FEI Number
3031884833
Entity Name
Bridge to Life Ltd
City/State/Country
Duluth, GA, US
Establishment Address
3300 Breckinridge Blvd Ste 200, Duluth, GA 30096, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Bridge to Life Ltd. (Owner Number: 10038889)
Owner / Operator Contact Address
3300 Breckinridge Blvd, Suite 200, Duluth, GA 30096, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K191006
PMA Number
N/A

All Registered Proprietary Names

Belzer MPS (UW Machine Perfusion Solution) Cannula for Organ Perfusion VitaSmart Hypothermic Oxygenated Perfusion System EasiSlush

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KDN System, Perfusion, Kidney Gastroenterology, Urology Class 2 876.5880 2025-07-15
KDL Set, Perfusion, Kidney, Disposable Gastroenterology, Urology Class 2 876.5880 2025-07-15
KDN System, Perfusion, Kidney Gastroenterology, Urology Class 2 876.5880 2022-09-01
MSB System And Accessories, Isolated Heart, Transport And Preservation Gastroenterology, Urology Class 2 876.5880 2022-09-01
SGY Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant Gastroenterology, Urology Class 2 876.5881 2026-01-16
KDN System, Perfusion, Kidney Gastroenterology, Urology Class 2 876.5880 2019-10-31

Official Correspondent

Danielle Rose Cox

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bridge to Life Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K013575 Organ Recovery Systems, Inc. KPS-I, THE KIDNEY PERFUSION SOLUTION 2002-01-25

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031884833. Last updated year: 2026. Please use registration number 3031884833 when referencing this establishment in official correspondence.
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