Drive DeVilbiss Vacu-Aide Suction Unit
Vacu-Aide w/battery, North America
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 | |
| Vega Technologies Inc. | Dongguan | Guangdong | Repacker / relabeller | 7 |
| Foshan Care Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 3 |
Record
| Listed by | Drive DeVilbiss Healthcare, United States |
|---|---|
| FDA product code | JCX |
| Device type | Apparatus, Suction, Ward Use, Portable, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4780 |
| Establishment | Repacker / relabeller |
| 510(k) | K982304 |
| Record published | 2022-01-07 |
| Record revised | 2023-12-04 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 77 to 106 KiloPascal; Handling environment humidity 15 to 93 % RH; Handling environment temperature 32 to 104 °F; Storage environment humidity 0 to 93 % RH; Storage environment temperature -13 to 140 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7325P-D | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeVilbiss | DeVilbiss Healthcare LLC. | 35 |
| Neptune | Stryker GmbH | 16 |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | Zimmer Orthopaedic Surgical Products | 16 |
| IntelliCart™ | Zimmer Orthopaedic Surgical Products | 13 |
| Penumbra System | Penumbra Inc. | 8 |
| Schuco | Allied Medical LLC | 7 |
| Gomco | Allied Medical LLC | 7 |
| Roscoe Medical | Drive DeVilbiss Healthcare | 5 |
| Cliq Aspirator | Anest Iwata Sparmax Co., Ltd. | 5 |
| Drive | Drive DeVilbiss Healthcare | 4 |
| Truvic Generator | Taiwan Biomaterial Company, Ltd. | 4 |
| Phantom | Innovative Med, Inc. | 4 |
Showing 12 of 65. All products under Apparatus, Suction, Ward Use, Portable, Ac-Powered
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| DeVilbiss Healthcare LLC. | 510(k) number | 2016-05-23 | Class II | Component design/selection | A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation. | 48 units | 2017-05-30 |
| DeVilbiss Healthcare LLC. | 510(k) number | 2013-03-07 | Class II | Use error | End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable. | 112,849 | 2014-11-06 |
| DeVilbiss Healthcare LLC. | 510(k) number | 2008-10-27 | Not classified | Device Design | Improper suction: Regulator knob does not turn properly which can affect the suction level. | 78 units | 2012-09-25 |
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.