Liberty® Select Cycler
Catalogue number 180343, listed by Fresenius Medical Care, United States, under System, Peritoneal, Automatic Delivery. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Viant Medical Suzhou EPZ Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Fresenius Medical Care, United States |
|---|---|
| FDA product code | FKX |
| Device type | System, Peritoneal, Automatic Delivery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5630 |
| 510(k) | K171652 |
| Record published | 2018-02-26 |
| Record revised | 2024-07-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -31 to 54 °C |
| Sizes | Weight 32 lb |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 180343 | Weight 32 lb | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sharesource Connectivity Platform | Baxter Healthcare Corporation | 7 |
| Peritoneal Dialysis | Merit Medical Systems, Inc. | 6 |
| Liberty® | Fresenius Medical Care | 5 |
| VersiPD | Fresenius Medical Care | 4 |
| VersiPD | Fresenius USA, Inc. | 3 |
| Liberty® PDx | Fresenius Medical Care | 3 |
| Liberty | Fresenius Medical Care Renal Therapies Group, LLC | 2 |
| Premier | Fresenius Medical Care | 2 |
| Safe-Lock® | Fresenius Medical Care | 2 |
| HomeChoice APD System | Baxter Healthcare Corporation | 2 |
| LOW Recirculation Volume APD SET | Baxter Healthcare Corporation | 2 |
| Sharesource | Baxter Healthcare Corporation | 2 |
Showing 12 of 38. All products under System, Peritoneal, Automatic Delivery
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2023-10-24 | Class III | Under Investigation by firm | Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic. | 149 US | |
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2020-09-12 | Class II | Device Design | The device may detect an incorrect Heater Bag volume which may lead to a ‘Supply Bag Line Blocked’ alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra f | 9,907 devices | |
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2018-01-24 | Class II | Software design | The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result in an increased risk of Overfill (also known as Increased Intraperitoneal Volume, IIPV). Overfill/IIPV may result in serious injury or d | 9293 | 2020-05-11 |
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.