Home Vision Monitor®
GUDID 00860004152705
The Home Vision Monitor® Model 0005 is a vision function test provided as a downloadable app on to the user’s supplied cell phone or tablet. The Home Vision Monitor® Model 0005 implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home. If a significant worsening of vision function is detected the physician will be notified and provided access to the vision self-test results so that they can decide whether the patient needs to be seen sooner than their next already scheduled appointment.
VITAL ART AND SCIENCE, LLC
Vision testing/training chart| Primary Device ID | 00860004152705 |
| NIH Device Record Key | e2b05443-1510-4125-b223-2adaf42676d8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Home Vision Monitor® |
| Version Model Number | Model 0005 |
| Company DUNS | 782794213 |
| Company Name | VITAL ART AND SCIENCE, 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 | 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860004152705 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143211
FDA Product Code
| HOQ | Grid, Amsler |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-25 |
| Device Publish Date | 2020-08-17 |
Trademark Results [Home Vision Monitor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HOME VISION MONITOR 86567654 4805761 Live/Registered |
GENENTECH, INC. 2015-03-18 |
 HOME VISION MONITOR 74296358 not registered Dead/Abandoned |
Eye Communications 1992-07-20 |
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