| Primary Device ID | 00840682104951 |
| NIH Device Record Key | bbc5f664-40e1-487d-adaa-9443c679e897 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | S4-10-D |
| 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 |
| Phone | +1(800)437-1171 |
| xx@xx.xx |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682104951 [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 |
| 00195278687777 - Venue Go | 2024-07-18 Venue Go R5 MD |
| 00195278703200 - Venue | 2024-07-18 Venue R5 final Assembly |
| 00195278703224 - Venue Fit | 2024-07-18 Venue Fit R5 Final Assembly |
| 00195278703453 - Venue Go | 2024-07-18 Venue Go R5 Final Assembly |
| 00195278703477 - Venue | 2024-07-18 Venue R5 MD |
| 00195278703484 - Venue Fit | 2024-07-18 Venue Fit R5 MD |
| 00195278754011 - Venue Sprint | 2024-07-18 Venue Sprint R5 MD |
| 00195278680938 - LOGIQ | 2023-12-12 LOGIQ E10 R4 Console |