Disposable High Pressure Syringe
The Disposable High Pressure Syringe family comprises plastic syringes for use with compatible angiography injectors. Packs can include connector tubing, a quick-fill tube and a spike; the…
The Disposable High Pressure Syringe family comprises plastic syringes for use with compatible angiography injectors. Packs can include connector tubing, a quick-fill tube and a spike; the latter two components draw fluid into the syringe.
Connector tubing joins the syringe to a catheter. WLP tubing has one syringe connector for single-shot syringes, while WLT and WLM tubing have two for dual-shot configurations. These tubing configurations have a maximum pressure rating of 350 psi.
Model and Injector Matching
Syringe capacity and injector connection vary by model. SEZ101, one model in the family, is a 200 mL single-shot syringe for the EZEM Empower CT injection system. Other models have their own injector assignments; accessories and injector compatibility depend on the selected pack.
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 | Union Medical Shenzhen Co., Ltd., China |
|---|---|
| FDA product code | DXT |
| Device type | Injector And Syringe, Angiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Manufacturer |
| 510(k) | K170279 |
| Record published | 2018-12-26 |
| Record revised | 2020-11-26 (version 2) |
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, manufacturing date |
| Packaging | Pack of 50, pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SLF301 | In distribution | |
| SEZ108 | In distribution | |
| SLF101 | In distribution | |
| SLF102 | In distribution | |
| SEZ103 | In distribution | |
| SLF202 | In distribution | |
| SMR301 | In distribution | |
| SLF108 | In distribution | |
| SMR101 | In distribution | |
| SEZ101 | In distribution | |
| SMR201 | In distribution | |
| SMR302 | In distribution | |
| SEZ109 | In distribution | |
| SLF103 | In distribution | |
| SLF302 | In distribution | |
| SEZ301 | In distribution | |
| SLF107 | 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 |
|---|---|
| K170279 | 2017-12-12 |
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.