Belzer UW Cold Storage Solution
Formulated for flushing and cold storage of kidney, liver and pancreas organs. 2000 mL
1manufacturer
3catalogue numbers in this listing
5510(k) clearances naming this product code
2recalls on this code
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 | Preservation Solutions, Inc., United States |
|---|---|
| FDA product code | KDN |
| Device type | System, Perfusion, Kidney |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5880 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| Record published | 2016-10-22 |
| Record revised | 2022-12-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 6, pack of 5, pack of 10 |
| Sizes | Total volume 500 to 2000 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BUW-500 | Total Volume 500 ml | In distribution |
| BUW-002 | Total Volume 2000 ml | In distribution |
| BUW-001 | Total Volume 1000 ml | 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 |
| 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 |
| 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 |
|---|---|
| K151728 | 2015-09-18 |
| K091245 | 2009-06-17 |
| K083453 | 2009-01-21 |
| K080432 | 2008-08-08 |
| K073693 | 2008-07-03 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Santanello Surgical LLC | UDI-DI | 2019-06-10 | Class II | Package design/selection | Lack of package integrity may compromise sterility | 98 | 2021-01-13 |
| Preservation Solutions, Inc. | UDI-DI | 2018-02-26 | Class II | Nonconforming Material/Component | Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag.. | 31,104 units | 2022-09-09 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-09-24 | Not classified | Labeling mix-ups | Mislabeled volume – 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter. | 55 units | 2012-04-02 |
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.