Medline Industries, Inc.
TBG Press 84IN M/F ROT BRD CLP
15manufacturers in China registered for this device type
59catalogue 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 |
| 510(k) | K170025 |
| Record published | 2022-08-04 |
| Record revised | 2026-01-12 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 50, case of 250, case of 500, case of 150, case of 12 |
| Distribution end date | 2026-07-07 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DNSC96725 | In distribution | |
| DNSC89370 | In distribution | |
| VASCSLPON1 | In distribution | |
| DNSC96726 | In distribution | |
| SAMPC0287 | In distribution | |
| DYNJBRTC84R | In distribution | |
| DYNJBRT10R | In distribution | |
| DYNJBRT48F | In distribution | |
| DYNJBRT20R | In distribution | |
| DYNJBRT96F | In distribution | |
| DYNJBRT60F | In distribution | |
| DYNJBRT84R | In distribution | |
| VASC1094 | In distribution | |
| DNSC96724 | In distribution | |
| DNSC81015 | In distribution | |
| VASC1087 | In distribution | |
| DYNJBRT10F | In distribution | |
| DYNJBRT60R | In distribution | |
| 259819 | In distribution | |
| SAMPC0281 | In distribution | |
| DYNJBRT30F | In distribution | |
| SAMPC0241 | In distribution | |
| DYNJZ127636 | In distribution | |
| DYNJBRT84F | In distribution | |
| DNSC96723 | In distribution | |
| DYNJBRT20F | In distribution | |
| SAMPC310 | In distribution | |
| DNSC89368 | In distribution | |
| DYNJBRT72R | In distribution | |
| DYNJBRT72F | In distribution | |
| DYNJBRTC72F | In distribution | |
| DYNJBRT96R | In distribution | |
| DNSC89371 | In distribution | |
| DYNJZ127637 | In distribution | |
| DYNJBRT30R | In distribution | |
| SAMPC0316 | In distribution | |
| DYNJBRT48R | In distribution | |
| DNSC88619 | In distribution | |
| DNSC89369 | In distribution | |
| DYNJBRTC96F | In distribution | |
| VASCSHPOFF1 | In distribution | |
| DNSC88618 | In distribution | |
| DYNJZ42972 | In distribution | |
| SAMPC0289 | In distribution | |
| VASCSLPOFF1 | In distribution | |
| DNSC81016 | In distribution | |
| DYNJBRTC10F | Withdrawn | |
| DYNJBRTC20R | Withdrawn | |
| DYNJBRTC84F | Withdrawn | |
| DYNJBRTC60F | Withdrawn | |
| DYNJBRTC48F | Withdrawn | |
| DYNJBRTC30R | Withdrawn | |
| DYNJBRTC48R | Withdrawn | |
| DYNJBRTC20F | Withdrawn | |
| DYNJBRTC30F | Withdrawn | |
| DYNJBRTC72R | Withdrawn | |
| DYNJBRTC60R | Withdrawn | |
| DYNJBRTC10R | Withdrawn | |
| DYNJBRTC96R | Withdrawn |
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 |
| 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 |
| 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
4 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. | 1698 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-25 | Class II | No Marketing Application | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. | 38,230 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-25 | Class II | No Marketing Application | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. | 58836 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-25 | Class II | No Marketing Application | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. | 198210 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.