PleurX
PleurX Pleural Catheter and Starter Kit - For Pleural Placement Only and For Patient Home Use
3manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1). 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 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
Record
| Listed by | Carefusion 2200, Inc., United States |
|---|---|
| FDA product code | DWM |
| Device type | Apparatus, Suction, Patient Care |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5050 |
| 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 | Special storage condition: Do not freeze; Storage environment temperature 15 to 30 °C |
| Packaging | Case of 10, case of 5, case, box |
| Sizes | Total volume 500 to 1000 ml; catheter gauge 15.5 Fr |
| Distribution end date | 2025-09-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50-7050 | In distribution | |
| 50-7000B | Catheter Gauge 15.5 Fr | In distribution |
| 50-7205B | Total Volume 500 ml | In distribution |
| 50-7700 | Total Volume 1000 ml | In distribution |
| 50-7270 | In distribution | |
| 50-7210 | Total Volume 1000 ml | In distribution |
| 50-0071 | Total Volume 1000 ml | In distribution |
| 50-7500B | Total Volume 500 ml | In distribution |
| 50-7265 | Withdrawn | |
| 50-7280 | Withdrawn | |
| 50-0075 | Total Volume 500 ml | Withdrawn |
| 50-7235 | Withdrawn | |
| 50-7245 | Withdrawn | |
| 50-7290 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aspira® | Merit Medical Systems, Inc. | 20 |
| Asept | B. Braun Interventional Systems, Inc. | 5 |
| Apparatus, Suction, Patient Care | Carefusion 2200, Inc. | 3 |
| Rocket | Rocket Medical PLC | 3 |
| Aspira Drainage Tray | Bard Access Systems, Inc. | 3 |
| Asept Pleural Drainage System | PFM Medical, Inc | 2 |
| Passio Redressing Kit | Bearpac Medical, LLC | 2 |
| Passio Handheld Control Unit | Bearpac Medical, LLC | 1 |
| Passio Disposable Collection System | Bearpac Medical, LLC | 1 |
| Passio Adapter Kit | Bearpac Medical, LLC | 1 |
| Aspira Drainage Kit | Bard Access Systems, Inc. | 1 |
| Passio Valve Cap Kit | Bearpac Medical, LLC | 1 |
Showing 12 of 17. All products under Apparatus, Suction, Patient Care
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.