BEL-GEN Cold Storage Solution
Institut Georges Lopez
INSTITUT GEORGES LOPEZ
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3024820181 | 3024820181 | INSTITUT GEORGES LOPEZ | 1 | N | 2026-01-01 | 6 ROUTE DE SAINT BONNET ST LAURENT DE CHAMOUSSET Rhone FR 69930 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 310384 | 1310697469 | K991594 | CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS | MSB | 1999-08-05 |
| 310384 | 1260425904 | K221387 | BEL-GEN Cold Storage Solution | KDL | 2022-06-14 |
| 310384 | 1123290729 | K221386 | PERF-GEN Pulsatile Perfusion Solution | KDL | 2022-06-14 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Perfusion Cannula - The Cannulation Set provide a connection between an explanted organ and an Organ Perfusion System. Particular compatibility is claimed with the Organ Perfusion System RM4.
2026-05-11
Perfusion Cannula - The Cannulation Set provide a connection between an explanted organ and an Organ Perfusion System. Particular compatibility is claimed with the Organ Perfusion System RM4.
2026-05-11
Perfusion Cannula - The Cannulation Set provide a connection between an explanted organ and an Organ Perfusion System. Particular compatibility is claimed with the Organ Perfusion System RM4.
2026-05-11
Perfusion Coupler - The Perfusion Coupler shall be used only with the DCX Organ Cassette or the DCM Organ Cassette.This accessory is supplied sterile, disposable and is a single-use device.The Perfusion Coupler has a 25cm length.
2025-05-26
DCX Disposable Cassette - The DCX Disposable Cassette is a sterile, disposable and single-use, organ cassette, which is used with a RM4 Control Unit, the whole constituting a system called RM4 Kidney Perfusion System. This organ cassette is intended to receive one or two kidneys from the same donor.The RM4 Kidney Perfusion System, is a lightweight and compact renal perfusion system intended to provide controlled perfusion of a hypothermic physiologic solution for the preservation of donor kidney organs before transplantation into the recipientThis system controls kidney perfusion of hypothermic physiologic solutions and monitors, displays, trends, and saves the perfusion parameters. To complete this set, various cannulas/clamps for arterial cannulation of the kidneys to the perfusate circuit into the cassette are used. They’re not provided with the DCX disposable cassette.
2025-05-26
Perfusion Coupler - The Perfusion Coupler shall be used only with the DCX Organ Cassette or the DCM Organ Cassette. This accessory is supplied sterile, disposable and is a single-use device. The Perfusion Coupler has a 25cm length.
2025-05-26
Perfusion Clamp with Adaptor - The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
2024-10-18
Perfusion Clamp with Adaptor - The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
2024-10-18
Perfusion Clamp with Adaptor - The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
2024-10-18
Perfusion Clamp with Adaptor - The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
2024-10-18
Perfusion Clamp with Adaptor - The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
2024-10-18
Perfusion Clamp with Adaptor - The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
2024-10-18
PARAGON-W (UW solution) - Clear, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs of kidney, liver and pancreas. 1L format
2023-12-22
PARAGON-W (UW solution) - Clear, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs of kidney, liver and pancreas. 2L format
2023-12-22
PARAGON-W (UW solution) - Clear, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs of kidney, liver and pancreas. 1L format
2023-12-22
PARAGON-W (UW solution) - Clear, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs of kidney, liver and pancreas. 2L format
2023-12-22
BEL-GEN Cold Storage Solution - Clear, sterile, non-pyrogenic solution for hypothermic flushing and storage of kidney, liver and pancreas.
2022-07-21
Waters IGL Cold Storage Solution - Clear, sterile, non-pyrogenic solution intended for hypothermic flushing and storage of kidney, liver and pancreas.
2023-05-24
Waters IGL Cold Storage Solution - Clear, sterile, non-pyrogenic solution intended for hypothermic flushing and storage of kidney, liver and pancreas.
2023-05-24
Perfusion Clamp - The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
2023-06-05
Perfusion Clamp - The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
2023-06-05
Perfusion Clamp - The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
2023-06-05
Perfusion Clamp - The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
2023-06-05
Perfusion Clamp - The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
2023-06-05
Perfusion Clamp - The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
2023-06-05
Waters IGL Pulsatile Perfusion Solution - Clear, sterile, non-pyrogenic solution intended for the in-vitro flushing and temporary continuous perfusion preservation of explanted kidneys
2023-05-24
Waters IGL Cold Storage Solution - Clear, sterile, non-pyrogenic solution intended for hypothermic flushing and storage of kidney, liver and pancreas.
2023-05-24
Waters IGL Cold Storage Solution - Clear, sterile, non-pyrogenic solution intended for hypothermic flushing and storage of kidney, liver and pancreas.
2023-05-24
Waters IGL Pulsatile Perfusion Solution - Clear, sterile, non-pyrogenic solution intended for the in-vitro flushing and temporary continuous perfusion preservation of explanted kidneys
2023-05-24
RM4 Kidney Perfusion System - RM4 Kidney Perfusion System is intended to be used for the pulsatile hypothermic machine perfusion of one or two kidneys for preservation and eventual transplantation into a recipient, only in healthcare professional environment.
2023-01-31
PERF-GEN Pulsatile Perfusion Solution - Clear, sterile, non-pyrogenic solution intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
2022-07-27
CELSIOR Cold Storage Solution - Sterile, non-pyrogenic cold flush, storage and transport solution for Hearts.
2022-02-07
BEL-GEN Cold Storage Solution - Clear, sterile, non-pyrogenic solution for hypothermic flushing and storage of kidney, liver and pancreas.
2022-01-31
PERF-GEN Pulsatile Perfusion Solution - Clear, sterile, non-pyrogenic solution intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
2022-07-27
BEL-GEN Cold Storage Solution - Clear, sterile, non-pyrogenic solution for hypothermic flushing and storage of kidney, liver and pancreas.
2022-07-21