Dover
Irrigation 1200 CC Tray, 60CC Piston Syringe, 500CC Container, TIP Protector, Alcohol, Lidded
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 | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | KYZ |
| Device type | Syringe, Irrigating (Non Dental) |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6960 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-04-10 |
| Record revised | 2025-12-31 (version 2) |
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 | Storage environment temperature 0 to 40 °C |
| Packaging | Case of 20, case of 50 |
| Sizes | Total volume 60 ml |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 68800 | Total Volume 60 ml | In distribution | |
| 67000 | Total Volume 60 ml | In distribution | |
| 680359 | 150 | In distribution | |
| 68000 | Total Volume 60 ml | In distribution | |
| 68820 | Total Volume 60 ml | In distribution | |
| 67800 | Total Volume 60 ml | In distribution | |
| 898029 | 125 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| FibriJet | Micromedics, Inc. | 35 |
| LSL Healthcare | Lsl Industries, Inc. | 24 |
| Medline | Medline Industries, Inc. | 21 |
| 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 |
Showing 12 of 129. All products under Syringe, Irrigating (Non Dental)
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-12-04 | Class I | Nonconforming Material/Component | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. | 63360 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.