| Primary Device ID | 00840682115247 |
| NIH Device Record Key | 338240a3-c8a7-41e1-beae-ee32086722da |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | i12L |
| Company DUNS | 623906971 |
| Company Name | GE PARALLEL DESIGN, INC. |
| 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 Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682115247 [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 | 2019-01-17 |
| Device Publish Date | 2016-07-15 |
| 00840682142366 - NA | 2020-08-17 |
| 00840682108676 - NA | 2020-05-05 |
| 00840682113045 - NA | 2019-01-21 |
| 00840682105231 - NA | 2019-01-18 |
| 00840682105248 - NA | 2019-01-18 |
| 00840682105255 - NA | 2019-01-18 |
| 00840682115216 - NA | 2019-01-18 |
| 00840682105262 - NA | 2019-01-17 |