| Primary Device ID | 00852745007130 |
| NIH Device Record Key | 7f9cf6d6-125a-4db5-887d-a238e56fbbca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BrainScope One International Charging Kit |
| Version Model Number | 99-1403-028 |
| Company DUNS | 805670416 |
| Company Name | BRAINSCOPE COMPANY, 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | 00852745007093 [Primary] |
| GS1 | 00852745007130 [Package] Contains: 00852745007093 Package: [1 Units] In Commercial Distribution |
| OLU | Normalizing Quantitative Electroencephalograph Software |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2018-09-24 |
| 00852745007284 - BrainScope One | 2024-06-12 This record is for BrainScope Part Number 99-1801-200 (SKU: BSO-3001) which is the BrainScope Ahead 500 CUBC1 Kit. Contains Devi |
| 00852745007260 - Baseline Headset | 2021-11-23 A variant of the electrode headset that is to be used for Baseline sessions. |
| 00852745007239 - BrainScope One | 2021-02-24 BrainScope Part Number 99-1801-100 (SKU: BSO-2001) Contains Device Identifier (DI) 00852745007222 - this is the DI for the Brain |
| 00852745007109 - Ahead 300 International Charging Kit | 2020-02-06 |
| 00852745007130 - BrainScope One International Charging Kit | 2020-02-06 |
| 00852745007130 - BrainScope One International Charging Kit | 2020-02-06 |
| 00852745007024 - Ahead 300 | 2018-10-25 |
| 00852745007048 - Ahead Electrode Headset | 2018-10-25 |
| 00852745007079 - Electrode Headset | 2018-10-25 |