| Primary Device ID | 00840682143165 |
| NIH Device Record Key | 24b0bb5b-6b8b-4784-9e8e-029dd75ca295 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | S4-10 |
| Company DUNS | 078863378 |
| Company Name | GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC |
| 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 -40 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682143165 [Primary] |
| ITX | Transducer, ultrasonic, diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-16 |
| Device Publish Date | 2018-10-16 |
| 00195278680938 - LOGIQ | 2023-12-12 LOGIQ E10 R4 Console |
| 00195278513014 - Venue Fit | 2022-07-08 Venue Fit R4 MD either eDelivery or physical |
| 00195278516480 - Venue | 2022-07-08 Venue R4 final Assembly |
| 00195278516497 - Venue Fit | 2022-07-08 Venue Fit R4 Final Assembly |
| 00195278516534 - Venue | 2022-07-08 Venue R4 MD either eDelivery or physical |
| 00195278516510 - Venue Go | 2022-07-05 Venue Go R4 Final Assembly |
| 00195278516541 - Venue Go | 2022-07-05 Venue Go R4 MD either eDelivery or physical |
| 00195278384041 - LOGIQ | 2021-11-23 LOGIQ E10 R3 Console |