Aspira®
20 catalogue numbers from 00884450394960, listed by Merit Medical Systems, Inc., 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
20catalogue numbers in this listing
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 | Merit Medical Systems, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2020-07-14 |
| Record revised | 2025-12-15 (version 5) |
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, manufacturing date |
| Packaging | Pack of 5, pack of 36, pack of 60, pack of 2, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450394960 | In distribution | |
| 00884450394922 | In distribution | |
| 00884450394984 | In distribution | |
| 00884450394861 | In distribution | |
| 00884450394915 | French Size (F)-15.5F | In distribution |
| 00884450544990 | French Size (F)-15.5F | In distribution |
| 00884450394939 | French Size (F)-15.5F | In distribution |
| 00884450394953 | In distribution | |
| A | French Size (F)-15.5F | In distribution |
| B | In distribution | |
| Initial Release | French Size (F)-15.5F | In distribution |
| B | In distribution | |
| 00884450394946 | French Size (F)-15.5F | In distribution |
| B | French Size (F)-15.5F | In distribution |
| 00884450398173 | French Size (F)-15.5F | In distribution |
| Initial Release | In distribution | |
| 00884450394977 | In distribution | |
| B | French Size (F)-15.5F | In distribution |
| B | French Size (F)-15.5F | In distribution |
| B | French Size (F)-15.5F | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K212696 | 2023-03-03 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Merit Medical Systems, Inc. | UDI-DI | 2023-04-22 | Class II | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. | 156 units |
| Merit Medical Systems, Inc. | UDI-DI | 2023-04-22 | Class II | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. | 524 units |
| Merit Medical Systems, Inc. | UDI-DI | 2023-04-22 | Class II | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. | 436 units |
| Merit Medical Systems, Inc. | UDI-DI | 2023-04-22 | Class II | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. | 1054 units |
| Merit Medical Systems, Inc. | UDI-DI | 2023-04-22 | Class II | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. | 2559 units |
| Mckesson Medical-Surgical Inc. Corporate Office | UDI-DI | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | a. 123 b. 407 |
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.