Suction Unit With Base
Catalogue number 10821, listed by Dynarex Corp., United States, under Apparatus, Suction, Ward Use, Portable, Ac-Powered. 5 manufacturers in China are registered for this product code.
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 | Dynarex Corp., 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 | Specification developer, Manufacturer |
| 510(k) | K042349 |
| Record published | 2019-11-06 |
| Record revised | 2024-10-09 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10821 | 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
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| EMG Technology Co., Ltd. | 510(k) number | 2014-08-03 | Class II | Nonconforming Material/Component | suction canister lids may have occluded ports. | 1452 | 2015-08-25 |
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.