Passio Redressing Kit
2 catalogue numbers from PAS-02, listed by Bearpac Medical, LLC, United States, under Apparatus, Suction, Patient Care. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Bearpac Medical, LLC, United States |
|---|---|
| FDA product code | DWM |
| Device type | Apparatus, Suction, Patient Care |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5050 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-29 |
| 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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2025-08-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PAS-02 | In distribution | |
| PAS-02 | Withdrawn |
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 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201404 | 2020-11-20 |
| K190292 | 2019-07-25 |
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.