| Primary Device ID | 06959385795923 |
| NIH Device Record Key | ecfc4af9-3d7f-4f32-a3d4-4048deb58c3d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BGEcare Disposable Face Mask |
| Version Model Number | MM17183060L1 |
| Company DUNS | 654591569 |
| Company Name | Zhende Medical Co., Ltd. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |