Sterimed
Drain Bag for Dornier/Siemens Table with 6mm Hose adapter
4manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
Record
| Listed by | Sterimed, Inc., United States |
|---|---|
| FDA product code | EYH |
| Device type | Table, Cysto, Non-Electrical |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4890 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-21 |
| Record revised | 2024-02-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Case of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DB2000 | In distribution | |
| DB2800 | In distribution | |
| DB1000 | In distribution | |
| DB1006 | In distribution | |
| DB1008 | In distribution | |
| DB3008 | In distribution | |
| DB3000 | In distribution |
Same Product Code
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.