REMI Vigilenz 20104
GUDID 00860005388189
REMI Vigilenz AI for Event Detection
Epitel, Inc.
Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software| 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 |
Customer Support Contacts
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860005388189 [Primary] |
FDA Product Code
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph |
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 | 2024-03-19 |
| Device Publish Date | 2024-03-11 |
Devices Manufactured by Epitel, Inc.
| 00860005388165 - REMI | 2024-03-19 REMI Wireless EEG Sensor |
| 00860005388189 - REMI Vigilenz | 2024-03-19REMI Vigilenz AI for Event Detection |
| 00860005388189 - REMI Vigilenz | 2024-03-19 REMI Vigilenz AI for Event Detection |
| 00860005388172 - REMI | 2023-11-27 REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Use Module |
| 00860011072423 - REMI | 2023-11-27 REMI Sticker |
| 00860011072430 - REMI | 2023-11-27 REMI Daily Sticker Kit |
| 08600053881278 - Epilog | 2022-01-10 Single-use continuous EEG monitor |
| 08600053881650 - REMI | 2022-01-10 REMI Tablet |
Trademark Results [REMI Vigilenz]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REMI VIGILENZ 98246840 not registered Live/Pending |
Epitel, Inc. 2023-10-30 |
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