Aspira Drainage Kit
Aspira Pleural Drainage Kit
3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Bard Access Systems, Inc., United States |
|---|---|
| FDA product code | DWM |
| Device type | Apparatus, Suction, Patient Care |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5050 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-11-20 |
| Record revised | 2025-12-15 (version 3) |
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 |
| Sizes | Catheter gauge 15.5 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4992508 | Catheter Gauge 15.5 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aspira® | Merit Medical Systems, Inc. | 20 |
| PleurX | Carefusion 2200, Inc. | 14 |
| 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 |
| Passio Valve Cap Kit | Bearpac Medical, LLC | 1 |
Showing 12 of 17. All products under Apparatus, Suction, Patient Care
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071095 | 2007-05-18 |
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.