REMI
GUDID 00860005388134
REMI Wireless EEG Sensor
Epitel, Inc.
Electroencephalographic monitoring system| Primary Device ID | 00860005388134 |
| NIH Device Record Key | d35adf76-4d14-4326-8ab4-212186c5cd75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REMI |
| Version Model Number | E001-20047 |
| Company DUNS | 808401157 |
| Company Name | Epitel, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 Dimensions
| Length | 1 Inch |
| Width | 1 Inch |
| Depth | 0.25 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Depth | 0.25 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Depth | 0.25 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Depth | 0.25 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Depth | 0.25 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Depth | 0.25 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Depth | 0.25 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Depth | 0.25 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Depth | 0.25 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Depth | 0.25 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Depth | 0.25 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Depth | 0.25 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Depth | 0.25 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Depth | 0.25 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Depth | 0.25 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Depth | 0.25 Inch |
| Length | 1 Inch |
| Width | 1 Inch |
| Depth | 0.25 Inch |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860005388103 [Primary] |
| GS1 | 00860005388134 [Package] Contains: 00860005388103 Package: Single Unit [1 Units] In Commercial Distribution |
| GS1 | 00860005388141 [Package] Contains: 10860005388100 Package: Shipper [4 Units] Discontinued: 2024-10-11 Not in Commercial Distribution |
| GS1 | 10860005388100 [Package] Contains: 00860005388103 Package: Carton [4 Units] In Commercial Distribution |
FDA Product Code
| OMC | Reduced- Montage Standard Electroencephalograph |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-10-14 |
| Device Publish Date | 2022-12-16 |
On-Brand Devices [REMI]
| 08600053881650 | REMI Tablet |
| 00860011072430 | REMI Daily Sticker Kit |
| 00860011072423 | REMI Sticker |
| 00860005388172 | REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Use Module |
| 00860005388165 | REMI Wireless EEG Sensor |
| 00860011072461 | REMI Server |
| 00860011072454 | REMI Ambulatory Patient Starter Kit |
| 00860011072447 | REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Use Module |
| 00860011072416 | REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Startup Module |
| 00860005388158 | REMI-Cloud |
| 00860005388110 | REMI EEG Monitoring Software |
| 00860005388134 | REMI Wireless EEG Sensor |
Trademark Results [REMI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REMI 98746946 not registered Live/Pending |
Ana S Olano 2024-09-12 |
 REMI 98444159 not registered Live/Pending |
Terean, LLC 2024-03-11 |
 REMI 98292939 not registered Live/Pending |
Rooke LLC 2023-11-30 |
 REMI 98170618 not registered Live/Pending |
Reimagine Care, Inc. 2023-09-08 |
 REMI 98093794 not registered Live/Pending |
Epitel, Inc. 2023-07-20 |
 REMI 98001768 not registered Live/Pending |
Celmatrix Corporation 2023-05-17 |
 REMI 97895118 not registered Live/Pending |
William Honjas 2023-04-18 |
 REMI 97588046 not registered Live/Pending |
Allspring Global Investments Holdings, LLC 2022-09-12 |
 REMI 97588043 not registered Live/Pending |
Allspring Global Investments Holdings, LLC 2022-09-12 |
 REMI 97298418 not registered Live/Pending |
At Play 2022-03-07 |
 REMI 97257125 not registered Live/Pending |
Stork Craft Manufacturing (USA) Inc. 2022-02-08 |
 REMI 97063709 not registered Live/Pending |
Integrity Implants Inc. 2021-10-07 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.