Dover
Catheter Care Kit
42manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (13), Zhejiang (8), Guangdong (7). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Inspiration MFG. & Trading Co. | Dongguan | Guangdong | Contract manufacturer | 8 |
| Anhui Medfaith Medical Devices Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
Showing 12 of 42. All 42 manufacturers in China registered for Brush, Scrub, Operating-Room
Record
| Listed by | Cardinal Health, United States |
|---|---|
| FDA product code | GEC |
| Device type | Brush, Scrub, Operating-Room |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-06-27 |
| Record revised | 2024-09-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep Dry;AVOID DIRECT SUNLIGHT |
| Packaging | Case of 50 |
| Distribution end date | 2024-08-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 95516 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 80000 Series Reusable General and Rigid Cleaning Brush | Primed Instruments, Inc. | 75 |
| Southmedic Instrument Cleaning Brushes | Southmedic, Inc. | 51 |
| Kendall | Cardinal Health | 14 |
| Novo Surgical | Novo Surgical, Inc. | 11 |
| Cardinal Health | Cardinal Health 200, LLC | 10 |
| Anchor | Team Technologies, Inc. | 8 |
| BR Surgical, LLC | BR Surgical LLC | 7 |
| Sklar® | Sklar Corporation | 6 |
| LSL Healthcare | Lsl Industries, Inc. | 5 |
| Medline Industries, Inc. | Medline Industries, Inc. | 4 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 4 |
| AMD-Ritmed | AMD Medicom Inc. | 3 |
Showing 12 of 22. All products under Brush, Scrub, Operating-Room
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.