| Primary Device ID | 03615220002610 |
| NIH Device Record Key | e879c775-0b52-44ca-bedd-be0b646d2eb9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neuronaute Application Mobile iOS |
| Version Model Number | 2.2.0 |
| Catalog Number | 5100-00012 |
| Company DUNS | 265828238 |
| Company Name | BIOSERENITY |
| 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 | 03615220002610 [Primary] |
| OUG | Medical Device Data System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-23 |
| Device Publish Date | 2021-02-15 |
| 03615220004270 - Bioserenity Cloud | 2023-08-29 Bioserenity CLOUD is a web-based information system that receives the EEG signals from the recorder through a paired Wi-Fi conne |
| 03615220004133 - Accusom | 2023-05-04 Sleep Apnea diagnostic Device |
| 03615220004140 - Accusom | 2023-05-04 Breath sensor |
| 03615220004157 - Accusom | 2023-05-04 Chest sensor |
| 03615220004171 - Neuronaute Touchproof Adapter | 2023-05-02 The Touchproof Adapter is an accessory of the Neuronaute IceCap, It's composed of a cable with sub-D25 female connector on one e |
| 03615220001521 - Neuronaute IceCap | 2021-02-23 The Neuronaute IceCap is intended to acquire, display, store, and archive EEG signals from the brain using a full montage array |
| 03615220001774 - Neuronaute 1.2 - Head module | 2021-02-23 Neuronaute Head Module is intended to acquire, display, store, and archive EEG signals from the brain using a full montage array |
| 03615220002573 - Bioserenity Cloud | 2021-02-23 |