Medline
Biomask,antiviral, Convex, Blue, LF
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OUK |
| Device type | Surgical Mask With Antimicrobial/Antiviral Agent |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Record published | 2016-10-14 |
| Record revised | 2023-09-13 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Pack of 25, case of 200 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BIOE3013A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RespoKare | Innonix Technologies Limited | 5 |
| ProGear/Oxafence | Prestige Ameritech | 3 |
| Meijer | Meijer, Inc. | 1 |
| Curad | Medline Industries, Inc. | 1 |
| Cufitec Surgical Mask | Nbc Meshtec, 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.