DCX Disposable Cassette

GUDID 13700911900577

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 recipient This 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.

INSTITUT GEORGES LOPEZ

Kidney donor-organ preservation/transport perfusion set

Primary Device ID	13700911900577
NIH Device Record Key	4b3a3ead-ed6a-4eda-a2b1-2e2dd133af75
Commercial Distribution Status	In Commercial Distribution
Brand Name	DCX Disposable Cassette
Version Model Number	DCX
Company DUNS	393146183
Company Name	INSTITUT GEORGES LOPEZ
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

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	13700911900577 [Primary]
GS1	23700911900574 [Package] Package: Carton Box [2 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K243998

FDA Product Code

KDN	System, Perfusion, Kidney

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	2025-06-03
Device Publish Date	2025-05-26

Devices Manufactured by INSTITUT GEORGES LOPEZ

13700911900577 - DCX Disposable Cassette	2025-06-03The 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 recipient This 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.
13700911900577 - DCX Disposable Cassette	2025-06-03 The DCX Disposable Cassette is a sterile, disposable and single-use, organ cassette, which is used with a RM4 Control Unit, the
23700911901052 - Perfusion Coupler	2025-06-03 The Perfusion Coupler shall be used only with the DCX Organ Cassette or the DCM Organ Cassette. This accessory is supplied steri
23700911900925 - Perfusion Clamp with Adaptor	2024-10-28 The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
23700911900932 - Perfusion Clamp with Adaptor	2024-10-28 The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
23700911900949 - Perfusion Clamp with Adaptor	2024-10-28 The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
23700911900659 - PARAGON-W (UW solution)	2024-01-01 Clear, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs of kidney, liver and pancreas. 1L format
23700911900666 - PARAGON-W (UW solution)	2024-01-01 Clear, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs of kidney, liver and pancreas. 2L format
23700911900628 - Perfusion Clamp	2023-06-13 The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.