| Primary Device ID | 00840682111416 |
| NIH Device Record Key | 58acd5f1-c2b2-4be3-a85b-8bbe7f57ea2b |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 12S-RS |
| 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 Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682111416 [Primary] |
| IYN | System, imaging, pulsed doppler, ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-01-18 |
| 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 |
| 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 |