Millennium
Ellik Rubber Ball Only
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Ucomfor Scientific Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 13 |
Record
| Listed by | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | FFD |
| Device type | Evacuator, Bladder, Manually Operated |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4370 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-23 |
| Record revised | 2023-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72-3434003 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Enteral | Gbuk Group Limited | 14 |
| Avanos | Avanos Medical, Inc. | 11 |
| Evacuator, Bladder, Manually Operated | Karl Storz GmbH & Co. KG | 7 |
| Porges Coloplast | Coloplast A/S | 4 |
| Vesco | Ucomfor Scientific Co., Ltd. | 4 |
| Strauss Surgical | American Medical Endoscopy | 4 |
| Wellead Evacuator | Well Lead Medical Co., Ltd. | 3 |
| Dual Action Pump Hand | Wismed PL SP Z O O | 1 |
| Hermann Medizintechnik GmbH | Hermann Medizintechnik Gmbh | 1 |
| Dual Action Pump Foot | Wismed PL SP Z O O | 1 |
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.