| Primary Device ID | 00860003376157 |
| NIH Device Record Key | 8f8fa246-d92e-43fc-b22a-62821dd3db27 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | myVisionTrack |
| Version Model Number | 1 |
| Company DUNS | 080811955 |
| Company Name | Brightinsight, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860003376157 [Primary] |
| QTW | Digital Amsler Grid |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-02-11 |
| Device Publish Date | 2024-01-09 |
| 00860003376157 | Vision testing application - iOS version |
| 00860003376119 | Vision testing application - HCP Portal |
| 00860003376102 | Vision testing application - android version |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MYVISIONTRACK 85684299 4475788 Live/Registered |
GENENTECH, INC. 2012-07-23 |