| Primary Device ID | 00840682116831 |
| NIH Device Record Key | d8ca97bc-ad4e-444e-ab76-c111624c14e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | E8Cs-RS |
| Company DUNS | 654658731 |
| Company Name | GE Medical Systems (China) Co.,Ltd. |
| 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 | 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 |
| Storage Environment Temperature | Between -5 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682116831 [Primary] |
| ITX | Transducer, ultrasonic, diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-07-15 |
| 00195278690401 - Versana | 2024-11-28 Magna R3 LOTUS 4pp Basic console |
| 00195278690418 - Versana | 2024-11-28 Magna R3 LOTUS 5pp Basic console |
| 00195278722430 - LOGIQ | 2024-11-28 Magna R3 LOGIQ F Basic console |
| 00195278690388 - Versana | 2024-11-05 Magna R3 VS Basic console |
| 00195278690395 - Versana | 2024-11-05 Magna R3 VA Basic console |
| 00195278466471 - NA | 2024-06-07 L4-20t-D |
| 00195278674197 - LOGIQ | 2023-12-28 LOGIQ e TP Standard Console |
| 00195278674203 - LOGIQ | 2023-12-28 LOGIQ e TB Standard Console |