RM4 Kidney Perfusion System
The RM4 Kidney Perfusion System preserves donor kidneys before transplantation by pumping a cooled physiological solution through them in pulses. It is intended for use in healthcare…
The RM4 Kidney Perfusion System preserves donor kidneys before transplantation by pumping a cooled physiological solution through them in pulses. It is intended for use in healthcare professional environments and accommodates one or two kidneys from the same donor.
The control unit regulates perfusion and monitors the perfusion parameters. It displays readings, shows their trends and saves the data. The kidneys sit in a sterile organ cassette, with arterial cannulas and clamps connecting them to the perfusate circuit.
Listed Item
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.
Cassette and Accessories
The organ cassette is disposable and intended for single use. An insulation cover is used with the cassette, while the control unit is supplied with a power cord and a USB flash drive containing its instructions for use.
Who Else Makes It
Registered in Fujian. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
Record
| 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) | K211224 |
| Record published | 2023-01-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RM4 | In distribution |
Same 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
| 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.