| Primary Device ID | 00840682115865 |
| NIH Device Record Key | ffae3c34-c7f9-48f8-a21d-4acfb2cb356c |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | L10-22-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 |
| Phone | +1(800)437-1171 |
| xx@xx.xx |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682115865 [Primary] |
| IYO | System, imaging, pulsed echo, ultrasonic |
| 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 | 2016-08-01 |
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| 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 |
| 00195278300034 - Versana | 2023-06-23 Supra R2 basic console for Balance VS |
| 00195278300096 - Versana | 2023-06-23 Supra R2 basic console for Balance VA |
| 00195278503404 - Versana | 2023-06-21 Versana Essential R2 VS |