| Primary Device ID | 00860005388189 |
| NIH Device Record Key | 50373930-a17c-47ca-badb-8fa4984b6528 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REMI Vigilenz |
| Version Model Number | 1.x.x |
| Catalog Number | 20104 |
| Company DUNS | 808401157 |
| Company Name | Epitel, Inc. |
| 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 |
| Phone | (801)497-6297 |
| support@epitel.com | |
| Phone | (801)497-6297 |
| support@epitel.com | |
| Phone | (801)497-6297 |
| support@epitel.com | |
| Phone | (801)497-6297 |
| support@epitel.com | |
| Phone | (801)497-6297 |
| support@epitel.com | |
| Phone | (801)497-6297 |
| support@epitel.com | |
| Phone | (801)497-6297 |
| support@epitel.com | |
| Phone | (801)497-6297 |
| support@epitel.com | |
| Phone | (801)497-6297 |
| support@epitel.com | |
| Phone | (801)497-6297 |
| support@epitel.com | |
| Phone | (801)497-6297 |
| support@epitel.com | |
| Phone | (801)497-6297 |
| support@epitel.com | |
| Phone | (801)497-6297 |
| support@epitel.com | |
| Phone | (801)497-6297 |
| support@epitel.com | |
| Phone | (801)497-6297 |
| support@epitel.com | |
| Phone | (801)497-6297 |
| support@epitel.com | |
| Phone | (801)497-6297 |
| support@epitel.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860005388189 [Primary] |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-19 |
| Device Publish Date | 2024-03-11 |
| 00860011072478 - REMI | 2025-03-17 REMI 4 Pack Disposable Sticker Accessory |
| 00860013649203 - REMI | 2025-03-17 REMI Daily Sticker Kit |
| 00860011072492 - REMI | 2025-02-18 REMI 4 Pack Disposable Sticker Accessory |
| 00860011072485 - REMI | 2024-12-03 REMI Server |
| 00860005388127 - REMI | 2024-10-15 REMI Tablet |
| 00860005388134 - REMI | 2024-10-14 REMI Wireless EEG Sensor |
| 00860005388110 - REMI | 2024-10-14 REMI EEG Monitoring Software |
| 00860005388158 - REMI | 2024-10-14 REMI-Cloud |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() REMI VIGILENZ 98246840 not registered Live/Pending |
Epitel, Inc. 2023-10-30 |