PleurX
PleurX Peritoneal Catheter and Starter Kit - For Peritoneal Placement Only and For Patient Home Use
2manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
Record
| Listed by | Carefusion 2200, Inc., United States |
|---|---|
| FDA product code | PNG |
| Device type | Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5630 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2017-06-12 |
| Record revised | 2026-05-21 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Case of 10, case of 5, case, box |
| Sizes | Catheter gauge 15.5 Fr; total volume 1000 ml |
| Distribution end date | 2025-09-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50-7262 | In distribution | |
| 50-7510 | Total Volume 1000 ml | In distribution |
| 50-9900 | Catheter Gauge 15.5 Fr | Withdrawn |
| 50-9000B | Catheter Gauge 15.5 Fr | Withdrawn |
| 50-9050 | Catheter Gauge 15.5 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aspira® | Merit Medical Systems, Inc. | 14 |
| PeritX | Carefusion 2200, Inc. | 6 |
| PeritX | Bard Peripheral Vascular, Inc. | 3 |
| Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | Carefusion 2200, Inc. | 2 |
| Asept Peritoneal Drainage System | PFM Medical, Inc | 1 |
| Asept | PFM Medical, Inc | 1 |
| Asept | B. Braun Interventional Systems, Inc. | 1 |
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.