| Primary Device ID | 00850019294156 |
| NIH Device Record Key | 10f40f95-3d8d-4a07-b349-9ad7f1592554 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASTM LEVEL 3 Surgical Face Mask |
| Version Model Number | 20-1003-FSM3 |
| Company DUNS | 117537165 |
| Company Name | Premier Guard Usa, LLC |
| Device Count | 1 |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850019294156 [Primary] |
| FXX | Mask, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-18 |
| Device Publish Date | 2021-05-10 |
| 00850019294156 | 3-ply, single-use disposable surgical mask with a ASTM Level 3 rating. Made with elastic ear lo |
| 00850019294019 | 3-ply, single-use disposable surgical mask with a ASTM Level 3 rating. Made with elastic ear lo |