Enteral
Enteral, Drainage Bag, EVA, Single Use Without Clamp, 500ml
3manufacturers in China registered for this device type
14catalogue numbers in this listing
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 | Gbuk Group Limited, United Kingdom |
|---|---|
| FDA product code | FFD |
| Device type | Evacuator, Bladder, Manually Operated |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4370 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-10-14 |
| Record revised | 2026-07-03 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, serial number |
| Packaging | Box of 20, peel pack of 50, peel pack of 4, case of 6, box of 4, case of 4 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DBP-250 | In distribution | |
| DBP-250HT | In distribution | |
| DBISO-500 | In distribution | |
| DBP-2000 | In distribution | |
| DBISO-1000 | In distribution | |
| DBISO-250 | In distribution | |
| DBP-1500 | In distribution | |
| DBISON-500 | In distribution | |
| DBISO-50 | In distribution | |
| DBP-1000 | In distribution | |
| DBP-1000HT | In distribution | |
| DBP-500 | In distribution | |
| DBP-500HT | In distribution | |
| DBISO-100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Millennium | Avalign Technologies, Inc. | 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.