CloudCath Sensor (Sensing Hardware)
Sensing Hardware
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 | Gastroklenz Inc. |
|---|---|
| FDA product code | FKX |
| Device type | System, Peritoneal, Automatic Delivery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5630 |
| Record published | 2022-08-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01PD001 | 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
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.