Dover
Urine Drainage Bag,Luer-Lock Sampling, Anti-Reflux Device, Drain Tube
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
Record
| Listed by | Cardinal Health, United States |
|---|---|
| FDA product code | EXR |
| Device type | Urinometer, Mechanical |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1800 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2026-05-27 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: ; |
| Packaging | Case of 10, case of 20 |
| Sizes | Total volume 150 to 1000 ml |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6600 | Total Volume 150 ml | Withdrawn |
| 6510 | Total Volume 1000 ml | Withdrawn |
Same Product Code
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.