| Primary Device ID | 00840682104999 |
| NIH Device Record Key | d694d01f-906b-408c-91c7-d2bfb4b17e58 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | E8CS-SC |
| 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 |
| Handling Environment Temperature | Between -5 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682104999 [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 | 2016-07-15 |
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| 00195278674203 - LOGIQ | 2023-12-28 LOGIQ e TB Standard Console |
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| 00195278503404 - Versana | 2023-06-21 Versana Essential R2 VS |
| 00195278503411 - Versana | 2023-06-21 Versana Essiential R2 VA |
| 00195278421388 - Vivid | 2022-09-07 Vivid iq R6 basic console |
| 00195278422279 - Vivid | 2022-09-07 T9 v206 console |