| Primary Device ID | 10850021617193 |
| NIH Device Record Key | 2affb57a-abd2-4be2-a56a-5a8725d64cb7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BRS Level 2 Procedure Mask with Ear Loops |
| Version Model Number | 850021617196 |
| Catalog Number | BRS2189 |
| Company DUNS | 117425172 |
| Company Name | Blackbriar Regulatory Services, 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 | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850021617196 [Primary] |
| GS1 | 10850021617193 [Package] Contains: 00850021617196 Package: Case [12 Units] In Commercial Distribution |
| 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 | 2021-04-12 |
| Device Publish Date | 2021-04-02 |
| 10850021617193 - BRS Level 2 Procedure Mask with Ear Loops | 2021-04-12Level 2 Procedure Face Mask with Ear Loops |
| 10850021617193 - BRS Level 2 Procedure Mask with Ear Loops | 2021-04-12 Level 2 Procedure Face Mask with Ear Loops |
| 00850021617578 - BRS Level 3 Procedure Face Mask - 3 Layers | 2021-04-12 Level 3 Procedure Face Mask with Ear Loops - 3 Layers |
| 10850021617001 - BRS Level 1 Procedure Face Mask with Ear Loops | 2021-04-06 Level 1 Procedure Face Mask with Ear Loops - Updated |