Cardinal Health
Kit,chp Wound Irrigation
110manufacturers in China registered for this device type
12catalogue numbers in this listing
1recall
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 | 2024-10-25 |
| Record revised | 2022-06-17 (version 5) |
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, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 14, case of 2, case of 25, case of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| WND33WICH9 | In distribution | |
| SAN45IRNCA | In distribution | |
| WND33WIC14 | In distribution | |
| WND33WIC10 | In distribution | |
| WND33WIC12 | In distribution | |
| WND33WIC13 | In distribution | |
| WND33WICH6 | In distribution | |
| 08-1661 | In distribution | |
| SANHFIPPCA | In distribution | |
| WND33WICH4 | In distribution | |
| SAN45IRNC1 | In distribution | |
| WND33WICH8 | In distribution |
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 |
| 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
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.