Optimus Gravity Drainage Bag
Optimus 600 Gravity Drainage Bag w/36" I.T.
1manufacturer
2catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Uresil, LLC, United States |
|---|---|
| FDA product code | EXF |
| Device type | Bag, Bile Collecting |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-11-04 |
| Record revised | 2025-08-06 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Shipper of 20, dispenser of 10, shipper of 2 |
| Sizes | Total volume 600 ml; length 20 to 36 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TC600L | Total Volume 600 ml | In distribution |
| TC600 | Total Volume 600 ml | 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 |
| 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 |
|---|---|
| K903449 | 1990-09-12 |
| K901844 | 1990-06-01 |
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.