Who else makes this device?

Name: DCX Disposable Cassette
Brand: DCX Disposable Cassette

Gastroenterology & Urology › TherapeuticSystem, Perfusion, Kidney

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…

Registry build 21.09.26

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.

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Fujian. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KDN
Manufacturer	City	Province	Registered as	Device types
Sanbor Medical Xiamen, Inc.	Xiamen	Fujian	Contract manufacturer	16

Record

Regulatory record for DCX Disposable Cassette
Listed by	Institut Georges Lopez, France
FDA product code	KDN
Device type	System, Perfusion, Kidney
Device class	Class 2
Regulation	21 CFR 876.5880
Establishment	Specification developer, Manufacturer
510(k)	K243998
Record published	2025-05-26

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 25 °C
Packaging	Carton box of 2

Catalogue Numbers

Catalogue numbers for DCX Disposable Cassette
Catalogue number	Size	Status
DCX		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
BAROguard	Paragonix Technologies, Inc.	7
LifePort® Kidney Transporter	Organ Recovery Systems, Inc.	5
KidneyVault	Paragonix Technologies, Inc.	5
KidneyVault Portable Renal Perfusion System	Paragonix Technologies, Inc.	3
PancreasPak	Paragonix Technologies, Inc.	3
Perfadex Plus®	Xvivo Perfusion AB	3
Perfusion Cannula	Institut Georges Lopez	3
Belzer UW Cold Storage Solution	Bridge to Life Ltd	3
Belzer UW Cold Storage Solution	Preservation Solutions, Inc.	3
X°Port Lung Preservation Solution	Traferox Technologies Inc.	3
LUNGguard	Paragonix Technologies, Inc.	2
Servator B Salf Solution	S.a.l.f. SPA Laboratorio Farmacologico	2

Showing 12 of 78. All products under System, Perfusion, Kidney

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K211224	2021-10-15

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.