6 catalogue numbers from 00884450277454, listed by Merit Medical Systems, Inc., United States, under System, Peritoneal, Automatic Delivery. 1 manufacturer in China is registered for this product code.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Peritoneal Dialysis | Listed by | Merit Medical Systems, Inc., United States |
| FDA product code | FKX |
| Device type | System, Peritoneal, Automatic Delivery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5630 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-10-10 |
| Record revised | 2025-05-12 (version 7) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 56 |
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.