Merit Drainage Depot™
4 catalogue numbers from 00884450008256, listed by Merit Medical Systems, Inc., United States, under Bag, Bile Collecting. 1 manufacturer in China is registered for this product code.
1manufacturer
4catalogue numbers in this listing
1510(k) clearance
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 | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | EXF |
| Device type | Bag, Bile Collecting |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2025-04-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 20, pack of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450008256 | In distribution | |
| 00884450232231 | In distribution | |
| 00884450025604 | In distribution | |
| T | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Biliary Drainage Kit | Marlen Manufacturing And Development Co. | 1 |
| Navarre | Bard Access Systems, Inc. | 1 |
| VacuBag | Bard Access Systems, Inc. | 1 |
| Drainage Bag | Remington Medical, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K003078 | 2000-12-11 |
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.