Medline
ASPIRATOR,SUCTION,W/800CC Canister
5manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | JCX |
| Device type | Apparatus, Suction, Ward Use, Portable, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4780 |
| 510(k) | K042349 |
| Record published | 2021-03-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Storage | Handling environment humidity 0 to 95 % RH; Storage environment humidity 0 to 95 % RH; Storage environment temperature -10 to 70 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 0 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HCS701311 | In distribution | |
| HCS7000 | 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.