Medline
SET, Suction Filters, Tubing
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen BI-Rich Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OJR |
| Device type | Vacuum Powered Body Fluid Collection Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4780 |
| Premarket notification | Exempt |
| Record published | 2022-07-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight. Keep product upright. Protect from freezing. Avoid excessive heat. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HCS7001SET | In distribution |
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.