Neptune 2
Specimen Collection 4-Port Manifold
5manufacturers in China registered for this device type
3catalogue numbers in this listing
2510(k) clearances naming this product code
6recalls on this code
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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | JCX |
| Device type | Apparatus, Suction, Ward Use, Portable, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4780 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2022-05-05 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0702025000 | In distribution | |
| 0702020001 | In distribution | |
| 0702020000 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153407 | 2016-04-25 |
| K132671 | 2013-12-20 |
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-07-01 | Class II | Under Investigation by firm | Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the device to experience system errors causing the device to shutdown if high levels of electromagnetic interference are present in the | 78 | 2017-06-02 |
| 2015-05-22 | Class II | Nonconforming Material/Component | Stryker Instruments is initiating a recall of the Neptune 2 Waste Management System due to complaints related to installation failures of the Neptune 2 diverter valve assembly during docking. | 9,245 | 2016-09-12 |
| 2013-12-30 | Class II | Device Design | The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications. | 2016-01-12 | |
| 2013-12-30 | Class II | Device Design | The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications. | 2016-01-12 | |
| 2011-05-24 | Class II | Component design/selection | Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover’s ability to r | 154 | 2014-05-28 |
| 2011-05-24 | Class II | Component design/selection | Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover’s ability to r | 5865 | 2014-05-28 |
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.