| Primary Device ID | 94710415369010 |
| NIH Device Record Key | 54eaad49-8c29-49a6-bb00-d7e5440d3250 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown |
| Version Model Number | IL-4036YKTP-L4 |
| Company DUNS | 658023890 |
| Company Name | MEDTECS (TAIWAN) CORP. |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 | false |