Disposable High Pressure Injector Syringe
The Disposable High Pressure Injector Syringe family delivers contrast medium or saline using a compatible powered injector. Configurations include individual syringes, syringe sets with…
The Disposable High Pressure Injector Syringe family delivers contrast medium or saline using a compatible powered injector. Configurations include individual syringes, syringe sets with connecting tubes and medicine aspirators, and separately packaged accessories.
Each syringe has a barrel, plunger and piston or plunger cap. One-way or multi-way connecting tubes link the syringe to the fluid pathway, while tubular or puncturing aspirators are used to draw fluid into the syringe.
Listed Item
2-200ml Syringe, 1-J-type Tubular Medicine Aspirator, 1-150cm Multi-way Connecting Tube, 2-10cm Straight Tube, 2-Punctured Medicine Aspirator
Configuration and Compatibility
Syringe volume, connector design and rated pressure vary by model. The two-200 mL configuration includes a multi-way tube and aspirators for a Medrad Stellant Double CT injector. Other models are configured for specific CT, MRI or angiographic injectors, with rated pressures of 300 or 1200 psi. These syringes are intended for single use.
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 | Wuxi Yushou Medical Appliances Co., Ltd., China |
|---|---|
| FDA product code | DXT |
| Device type | Injector And Syringe, Angiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K152906 |
| Record published | 2021-01-31 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 200150A | In distribution | |
| 200200A/200200A | In distribution | |
| 200150B | In distribution | |
| 101200A/101200A | In distribution | |
| 100100D | In distribution | |
| 100200B/100200B | In distribution | |
| 300130A | In distribution | |
| 100200A | In distribution | |
| 10060A/10060A | In distribution | |
| 300200B/300100B | In distribution | |
| 300100B | In distribution | |
| 300100B/300100B | In distribution | |
| 100100B | In distribution | |
| 200200A | In distribution | |
| 100100C/100100C | In distribution | |
| 100130A | In distribution | |
| 100150C | In distribution | |
| 100100A | In distribution | |
| 300200B | In distribution | |
| 101100A/101100A | In distribution | |
| 100150A | In distribution | |
| 300200B/100060B | In distribution | |
| 101200A | In distribution | |
| 10060C/10060C | In distribution | |
| 300200B/300200B | In distribution | |
| 100060B/100060B | In distribution | |
| 100100C/10060A | In distribution | |
| 100200D | In distribution | |
| 100200B | 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 |
|---|---|
| K152906 | 2016-11-22 |
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.