| Primary Device ID | 00840682114455 |
| NIH Device Record Key | a46cbf90-7c81-4780-91ae-d2de0f137023 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | E8CS |
| Company DUNS | 391532137 |
| Company Name | PARALLEL DESIGN |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682114455 [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 | 3 |
| Public Version Date | 2018-05-23 |
| Device Publish Date | 2016-07-15 |
| 00840682110976 - NA | 2019-01-18 |
| 00840682111157 - NA | 2019-01-18 |
| 00840682111263 - NA | 2019-01-18 |
| 00840682111416 - NA | 2019-01-18 |
| 00840682115346 - NA | 2019-01-18 |
| 00840682124355 - NA | 2019-01-18 |
| 00840682124768 - NA | 2019-01-18 |
| 00840682136075 - NA | 2018-11-02 |