| Primary Device ID | 00840682141291 |
| NIH Device Record Key | dd097498-4601-49da-a4c0-3adcd26e51e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | B1X5 Software Upgrade |
| Version Model Number | V1.5 |
| Company DUNS | 784985108 |
| Company Name | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, 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 | false |
| Manufacturing Date | true |
| 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 | 00840682141291 [Primary] |
| OLW | Index-generating 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 | 2021-11-10 |
| Device Publish Date | 2020-11-18 |
| 00195278789846 - Mural Clinical Viewer | 2024-03-21 MD Mural Clinical Viewer 1.2 MEDICAL DEVICE |
| 00840682139250 - Portrait CAU01 | 2023-10-13 Portrait Clinical Alarming Unit CAU01 |
| 00195278330413 - Portrait CVA01 | 2023-09-11 PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2 |
| 00195278341129 - Portrait CSS01 | 2023-09-11 PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3 |
| 00195278577559 - Mural Clinical Viewer | 2023-07-24 MD Mural Clinical Viewer MEDICAL DEVICE |
| 00195278571342 - ONE-CUF | 2023-05-24 ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, SINGLE |
| 00195278571359 - ONE-CUF | 2023-05-24 ONE-CUF, INFANT, 1 TB BAYONET, 08 - 13 CM SINGLE |
| 00195278571366 - ONE-CUF | 2023-05-24 ONE-CUF, ADULT LONG, DINACLICK 5 , 23 - 33 CM, SINGLE |