Coeur Nemoto
50mL /50mL Disposable MR Dual Syringe Pack includes (1) 96” Y-Set / (2) Check Valves / (2) Spikes
15manufacturers in China registered for this device type
25catalogue numbers in this listing
11510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (3), Shandong (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 15 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Jiangxi Baoeran Biomedical Science & Technology Co., Ltd. | Fuzhou | Jiangxi | Contract manufacturer | 1 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Shandong INT Medical Instruments Co., Ltd. | Rizhao | Shandong | Manufacturer | 4 |
| Zhuhai DR Medical Instruments Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 4 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Showing 12 of 15. All 15 manufacturers in China registered for Injector And Syringe, Angiographic
Record
| Listed by | Coeur, Inc., United States |
|---|---|
| FDA product code | DXT |
| Device type | Injector And Syringe, Angiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| 510(k) | K051799 |
| Record published | 2016-07-14 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep product in clean, dry location. Avoid direct rays, heat and high humidity, and ultraviolet rays such as a germicida |
| Packaging | Shipper of 50, shipper of 20, shipper of 2, case of 50, shipper of 8, case of 25 |
| Sizes | Total volume 50 to 200 ml; length 8 to 60 in; total volume 100 Microliter |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C855-5106 | Total Volume 100 ml | In distribution |
| C855-5308 | Total Volume 100 ml | In distribution |
| C855-5408 | Total Volume 200 ml | In distribution |
| C855-5202 | Total Volume 200 ml | In distribution |
| C855-5206 | Total Volume 200 ml | In distribution |
| C855-5050 | Total Volume 50 ml | In distribution |
| C455-1500 | Length 60 in | In distribution |
| C855-5404 | Total Volume 200 ml | In distribution |
| C855-5079 | Total Volume 50 ml | In distribution |
| C855-5174 | Total Volume 100 ml | In distribution |
| C855-5125 | Total Volume 125 ml | In distribution |
| C455-0060 | Length 60 in | In distribution |
| C455-2151 | Length 60 in | In distribution |
| C855-5100 | Total Volume 100 ml | In distribution |
| C855-5101 | Total Volume 100 ml | In distribution |
| C855-5155 | Total Volume 50 ml | In distribution |
| C455-0904 | Length 8 in | In distribution |
| C855-5102 | In distribution | |
| C855-5059 | Total Volume 50 ml | In distribution |
| C855-5178 | Total Volume 100 ml | In distribution |
| C855-5258 | Total Volume 50 ml | In distribution |
| C855-5201 | Total Volume 200 ml | In distribution |
| C855-5200 | Total Volume 200 ml | In distribution |
| C855-5304 | Total Volume 200 ml | In distribution |
| C855-5150 | Total Volume 150 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sinton Medical Products | Shenzhen Boon Medical Supply Co., Ltd. | 199 |
| DeRoyal | Deroyal Industries, Inc. | 138 |
| Antmed | Shenzhen Antmed Co., Ltd. | 91 |
| Medline Industries, Inc. | Medline Industries, Inc. | 59 |
| LF | Liebel-Flarsheim Company LLC | 58 |
| Namic | Medline Industries, Inc. | 50 |
| Merit Medical® | Merit Medical Systems, Inc. | 46 |
| Medical Imaging Solutions International | Shenzhen Boon Medical Supply Co., Ltd. | 43 |
| LF | Shenzhen Boon Medical Supply Co., Ltd. | 38 |
| Namic | Navilyst Medical, Inc. | 38 |
| Coeur | Coeur, Inc. | 38 |
| Medical Imaging Solutions Intl. | Medical Imaging Solutions, Inc. | 37 |
Showing 12 of 168. All products under Injector And Syringe, Angiographic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170431 | 2017-08-18 |
| K161471 | 2016-10-06 |
| K150902 | 2015-10-22 |
| K142745 | 2015-04-01 |
| K140469 | 2014-07-28 |
| K133600 | 2014-04-30 |
| K120892 | 2013-06-10 |
| K090487 | 2009-10-19 |
| K070798 | 2007-10-04 |
| K051799 | 2005-11-02 |
| K032920 | 2003-12-16 |
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.