Perfadex Plus (Click US)
Perfadex Plus is a solution for flushing, cold static storage and transport of isolated donor lungs before transplantation into a recipient. It is used after the lungs have been removed…
Perfadex Plus is a solution for flushing, cold static storage and transport of isolated donor lungs before transplantation into a recipient. It is used after the lungs have been removed from the donor to support their preservation during that interval.
The solution is an extracellular dextran 40 formulation containing calcium. It is buffered with tromethamine, also called THAM, so additional buffering is not required before use. The formulation provides the fluid used for cooling and preserving the lungs.
Listed Item
PERFADEX Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. Package size: 10 x 1000ml
Click-Port Packaging
The solution is packaged in an Ecobag with a Click System port. A connector clicks onto the port to establish the fluid connection. The listed presentation contains ten 1,000mL bags.
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 | Xvivo Perfusion AB, Sweden |
|---|---|
| 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 |
| 510(k) | K170826 |
| Record published | 2019-12-04 |
| Record revised | 2022-12-08 (version 2) |
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, serial number |
| Storage | Storage environment temperature 2 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 19850 | 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 |
|---|---|
| K261644 | 2026-07-23 |
| K211333 | 2022-01-20 |
| K170826 | 2018-06-22 |
| K091989 | 2010-10-01 |
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.