Asept Peritoneal Drainage System
Catalogue number M7008, listed by PFM Medical, Inc, United States, under Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
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 | PFM Medical, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K093796 |
| Record published | 2015-10-15 |
| Record revised | 2019-09-06 (version 4) |
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 |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M7008 | 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 |
| PeritX | Bard Peripheral Vascular, Inc. | 3 |
| Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | Carefusion 2200, Inc. | 2 |
| Asept | PFM Medical, Inc | 1 |
| Asept | B. Braun Interventional Systems, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241278 | 2025-01-14 |
| K221779 | 2023-05-02 |
| K093796 | 2010-02-26 |
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.