X°Port Lung Preservation Solution
X°Port Lung Preservation Solution is used to flush and preserve isolated donor lungs before transplantation. It supports cold static storage and transport, remaining in the lung vasculature…
X°Port Lung Preservation Solution is used to flush and preserve isolated donor lungs before transplantation. It supports cold static storage and transport, remaining in the lung vasculature during preservation. The solution is separate from the insulated transport system with which it can be used.
It is a sterile, nonpyrogenic, low potassium dextran solution. The fluid is cooled to 4 to 8 degrees Celsius for perfusion and supports subsequent storage and transport at 4 to 10 degrees Celsius. The formulation is a lightly buffered, colloid-based extracellular preservation medium.
Listed Item
The X°Port Lung Preservation Solution is used for flushing, static cold storage, and the perfusion and preservation of lungs intended for transplantation. Package Size: 3 x 2000ml and 2 x 1000ml.
Preparation Requirements
Before use, the solution’s pH is adjusted with THAM solution. The specified preparation also requires calcium chloride supplementation at 0.5 millimoles per litre.
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 | 2025-09-11 |
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 |
| Packaging | Pack of 5, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 910-0003-2L | In distribution | |
| 910-0003-1L | In distribution | |
| 910-0003-8L-PKG | 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 |
| LUNGguard | Paragonix Technologies, Inc. | 2 |
| Servator B Salf Solution | S.a.l.f. SPA Laboratorio Farmacologico | 2 |
| Waters IGL Cold Storage Solution | Institut Georges Lopez | 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.