| 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 |
| 00840682119030 - NA | 2025-05-22 SOFT-CUF, LARGE ADULT LONG, 2 TB INFLATION SYSTEM, 31 - 40 CM, SINGLE |
| 00840682119085 - NA | 2025-05-22 SOFT-CUF, SMALL ADULT, 2 TB INFLATION SYSTEM, 17 - 25 CM, SINGLE |
| 00840682106009 - SOFT-CUF | 2025-05-16 SOFT-CUF, NEONATAL1, 2 TB MALE SLIP, 03 - 06 CM, SINGLE |
| 00840682106122 - SOFT-CUF | 2025-05-16 SOFT-CUF, NEONATAL2, 1 TB MALE SLIP, 04 - 08 CM, SINGLE |
| 00840682106146 - SOFT-CUF | 2025-05-16 SOFT-CUF, NEONATAL1, 1 TB MALE SLIP, 03 - 06 CM, SINGLE |
| 00840682106160 - SOFT-CUF | 2025-05-16 SOFT-CUF, NEONATAL4, 2 TB MALE SLIP, 07 - 13 CM, SINGLE |
| 00840682106207 - SOFT-CUF | 2025-05-16 SOFT-CUF, NEONATAL5, 2 TB MALE SLIP, 08 - 15 CM, SINGLE |
| 00840682106269 - SOFT-CUF | 2025-05-16 SOFT-CUF, NEONATAL3, 2 TB MALE SLIP, 06 - 11 CM, SINGLE |