Namic
MTO Syringe 8 ML TR/FR MLL NO RES OEM PG
15manufacturers in China registered for this device type
50catalogue numbers in this listing
1510(k) clearance
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | DXT |
| Device type | Injector And Syringe, Angiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Record published | 2021-05-12 |
| Record revised | 2024-10-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10, case of 80, box of 25, case of 100, case of 20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 80505103 | FALSE | 50 | In distribution |
| 70084017 | In distribution | ||
| 70506203 | In distribution | ||
| 80097003 | FALSE | 50 | In distribution |
| 80083007 | FALSE | 50 | In distribution |
| 80075023 | FALSE | 50 | In distribution |
| 80095003 | FALSE | 50 | In distribution |
| 70083003 | In distribution | ||
| 70098107 | In distribution | ||
| 70098007 | In distribution | ||
| 80085007 | FALSE | 50 | In distribution |
| 70085005 | In distribution | ||
| 70098003 | In distribution | ||
| 80083017 | FALSE | 50 | In distribution |
| 80095107 | FALSE | 50 | In distribution |
| 80506203 | FALSE | 50 | In distribution |
| 70097107 | In distribution | ||
| 80083003 | FALSE | 50 | In distribution |
| 80087003 | FALSE | 50 | In distribution |
| H74904494102 | In distribution | ||
| 70087107 | In distribution | ||
| 70087007 | In distribution | ||
| 80084013 | FALSE | 50 | In distribution |
| 80095007 | FALSE | 50 | In distribution |
| 70087003 | In distribution | ||
| 70095007 | In distribution | ||
| 70505103 | In distribution | ||
| 80083013 | FALSE | 50 | In distribution |
| 80084007 | FALSE | 50 | In distribution |
| 70085107 | In distribution | ||
| 70088007 | In distribution | ||
| 70088003 | In distribution | ||
| 70097007 | In distribution | ||
| 70084003 | In distribution | ||
| 70075027 | In distribution | ||
| 70085007 | In distribution | ||
| 80097107 | FALSE | 50 | In distribution |
| 70085003 | In distribution | ||
| 80084003 | FALSE | 50 | In distribution |
| 70095003 | In distribution | ||
| 70095107 | In distribution | ||
| 80085003 | FALSE | 50 | In distribution |
| 80087007 | FALSE | 50 | In distribution |
| 80084017 | FALSE | 50 | In distribution |
| 70085004 | In distribution | ||
| 80075027 | FALSE | 50 | In distribution |
| 70075023 | In distribution | ||
| 70084007 | In distribution | ||
| 70083007 | In distribution | ||
| 70097003 | 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 |
| 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 |
| CVi® Cable | Acist Medical Systems, Inc. | 30 |
Showing 12 of 168. All products under Injector And Syringe, Angiographic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K093830 | 2011-03-03 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-27 | Class I | Under Investigation by firm | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | 2630369 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-27 | Class I | Under Investigation by firm | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | 192690 units |
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.