| Primary Device ID | 00841983104275 |
| NIH Device Record Key | 3ddf0066-7f39-49e9-9a26-29892000f471 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VitalEEG Portable System |
| Version Model Number | AE-120A |
| Catalog Number | AE-120A |
| Company DUNS | 021063219 |
| Company Name | NIHON KOHDEN AMERICA, 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 | 00841983104275 [Primary] |
| OMC | Reduced- Montage Standard Electroencephalograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-14 |
| Device Publish Date | 2020-08-06 |
| 00841983104275 | Nihon Kohden VitalEEG Portable system with AE-120A EEG Head Set and Nihon Kohden EEG Acquisition |
| 00841983104282 | Nihon Kohden VitalEEG Portable system with AE-120A EEG Head Set and Nihon Kohden EEG Acquisition |