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DCX Disposable Cassette

FDA UDI

Class II (US FDA UDI)

by Institut Georges Lopez

Identity

Trade Name
DCX Disposable Cassette FDA UDI
Generic Name
Kidney donor-organ preservation/transport perfusion set FDA UDI
Device Name
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. FDA UDI
Model / Reference
DCX FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
13700911900577 FDA UDI
510(k) Number
K243998 FDA UDI
FDA Product Code
KDN FDA UDI
GMDN Term
Kidney donor-organ preservation/transport perfusion set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5880 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Kidney donor-organ preservation/transport perfusion set

DCX Disposable Cassette by Institut Georges Lopez — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Kidney donor-organ preservation/transport perfusion set.

Cleared under the same submission

K243998 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Institut Georges Lopez

Sources (1)

  • FDA UDI 4b3a3ead-ed6a-4eda-a2b1-2e2dd133af75 35 fields · synced May 30, 2026