| Primary Device ID | 00814901021442 |
| NIH Device Record Key | adf86d19-8835-4865-a2ff-fff134f3c9d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Digital NeuroPort Biopotential Signal Processing System |
| Version Model Number | 12126 |
| Catalog Number | 12126 |
| Company DUNS | 827132015 |
| Company Name | BLACKROCK MICROSYSTEMS, LLC |
| 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 | 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 | 00814901021442 [Primary] |
| GWL | Amplifier, Physiological Signal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-28 |
| Device Publish Date | 2022-09-20 |
| 00814901021404 | Digital Hub |
| 00814901021398 | Non-Sterile Digital Data Cable 1.5m |
| 00814901021381 | Non-Sterile NeuroPlex E128 Digital Headstage |
| 00814901021374 | Non-Sterile NeuroPlex E96 Digital Headstage |
| 00814901021367 | Sterile Digital Data Cable 1.5m |
| 00814901021350 | Sterile NeuroPlex E128 Digital Headstage |
| 00814901021343 | Sterile NeuroPlex E96 Digital Headstage |
| 00814901021442 | Gemini Hub Neural Signal Processor |
| 00814901021435 | Gemini Neural Signal Processor |
| 00814901021534 | Gemini Neural Signal Processor |
| 00814901021527 | Gemini Hub Neural Signal Processor |