X°Port Lung Preservation System
The X°Port Lung Preservation System stores and transports donated human lungs under static cold conditions before transplantation. An insulated chamber and phase-change cooling packs…
The X°Port Lung Preservation System stores and transports donated human lungs under static cold conditions before transplantation. An insulated chamber and phase-change cooling packs maintain a temperature range of 4 to 10 degrees Celsius.
A cradle holds the lung bag inside the chamber. A probe measures temperature, and a logger records it for display on an external screen; a mobile application can also monitor the internal temperature.
Listed Item
Lung Preservation System
Transport and Storage
The system has wheels and a telescopic handle for transport and is intended for use with X°Port Lung Preservation Solution. Intended organ storage time is up to eight hours. Lungs exceeding clinically accepted preservation times require transplant surgeon assessment of transplantability.
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 | Traferox Technologies Inc., Canada |
|---|---|
| FDA product code | KDN |
| Device type | System, Perfusion, Kidney |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5880 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K243870 |
| Record published | 2025-05-26 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 909-0011 | 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 |
|---|---|
| K260456 | 2026-06-01 |
| K243870 | 2025-05-01 |
| K240650 | 2024-11-26 |
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.