PeritX
PeritX™ 2L Drainage Starter Pack
2manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
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 | Bard Peripheral Vascular, 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 | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2025-01-23 |
| Record revised | 2025-12-15 (version 2) |
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 |
| Packaging | Case of 20, case of 5, case of 10 |
| Sizes | Total volume 2 l |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90-2020 | Total Volume 2 l | In distribution |
| 90-2005 | Total Volume 2 l | In distribution |
| 90-2010 | Total Volume 2 l | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aspira® | Merit Medical Systems, Inc. | 14 |
| PeritX | Carefusion 2200, Inc. | 6 |
| PleurX | Carefusion 2200, Inc. | 5 |
| 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241946 | 2024-12-06 |
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.