Biliary Drainage Kit
Biliary Drainage Kit BK-6
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
Record
| Listed by | Marlen Manufacturing And Development Co. |
|---|---|
| FDA product code | EXF |
| Device type | Bag, Bile Collecting |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Premarket notification | Exempt |
| Record published | 2026-05-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31803 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Merit Drainage Depot™ | Merit Medical Systems, Inc. | 4 |
| Drainage Bag | Uresil, LLC | 2 |
| Drainage Bag | Argon Medical Devices, Inc. | 2 |
| Gravity Drainage Bag | Uresil, LLC | 2 |
| Optimus Gravity Drainage Bag | Uresil, LLC | 2 |
| Navarre | Bard Access Systems, Inc. | 1 |
| VacuBag | Bard Access Systems, Inc. | 1 |
| Drainage Bag | Remington Medical, Inc. | 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.