Medline
Tray,irrigatn,bulb SYRGE,60ML,LIDDED,ALC
110manufacturers in China registered for this device type
21catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (31), Guangdong (27), Zhejiang (26). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Wenzhou Zuoyou Medical Technoloyg Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 21 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
Showing 12 of 110. All 110 manufacturers in China registered for Syringe, Irrigating (Non Dental)
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | KYZ |
| Device type | Syringe, Irrigating (Non Dental) |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6960 |
| Premarket notification | Exempt |
| Record published | 2021-03-18 |
| Record revised | 2025-04-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Protect from freezing, avoid excessive heat. |
| Packaging | Case of 50, case of 20, pack of 50, carton of 20 |
| Sizes | Total volume 60 to 90 ml; total volume 3 Fluid Ounce |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYND20102 | Total Volume 60 ml | In distribution |
| DYND20125 | In distribution | |
| DYNDE20125 | In distribution | |
| DYND20126 | In distribution | |
| DYND20324 | In distribution | |
| M103111B | In distribution | |
| DYND20302 | In distribution | |
| DYND20300 | In distribution | |
| DYND20323 | In distribution | |
| DYND70280 | In distribution | |
| DYND70277 | Total Volume 90 ml | In distribution |
| DYNC2303 | In distribution | |
| VDYND20302 | In distribution | |
| M103103B | In distribution | |
| DYND70279 | In distribution | |
| ENT6006M | In distribution | |
| M103112B | In distribution | |
| DYND20325 | In distribution | |
| URO70283 | In distribution | |
| DYND20100 | Total Volume 60 ml | In distribution |
| DYND11820 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| FibriJet | Micromedics, Inc. | 35 |
| LSL Healthcare | Lsl Industries, Inc. | 24 |
| Baria | Shenzhen Baria Technology Co., Ltd. | 20 |
| Monoject | Cardinal Health 200, LLC | 17 |
| Centurion | Centurion Medical Products Corporation | 17 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 14 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 12 |
| Ear and Ulcer Syringe | C.R. Bard, Inc. | 12 |
| Cardinal Health | Cardinal Health 200, LLC | 12 |
| Nordson Medical | Micromedics, Inc. | 10 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 9 |
| Rospital Productos Medicos | Atlas Medical Products LLC | 9 |
Showing 12 of 129. All products under Syringe, Irrigating (Non Dental)
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2024-01-04 | Class II | Under Investigation by firm | Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot num | 4831 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.