| Primary Device ID | 00852745007123 |
| NIH Device Record Key | 4b820149-bdfe-4636-b709-250e80e54b64 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BrainScope One |
| Version Model Number | 99-1403-002 |
| 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 | true |
| 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 | 00852745007123 [Primary] |
| OLU | Normalizing Quantitative Electroencephalograph Software |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-25 |
| Device Publish Date | 2018-09-24 |
| 00852745007123 | 99-1403-002 |
| 00852745007239 | BrainScope Part Number 99-1801-100 (SKU: BSO-2001) Contains Device Identifier (DI) 0085274500722 |
| 00852745007284 | This record is for BrainScope Part Number 99-1801-200 (SKU: BSO-3001) which is the BrainScope Ah |