| Primary Device ID | 00690103201130 |
| NIH Device Record Key | 6e4ae7c5-9dd4-4e03-8f78-f08516b2f4c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACUMEN IQ SENSOR |
| Version Model Number | AIQS8S102 |
| Catalog Number | AIQS8S102 |
| Company DUNS | 134139174 |
| Company Name | Edwards Lifesciences LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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)822-9637 |
| tech_support@edwards.com |
| Length | 84 Inch |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DRY PLACE |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00690103201130 [Primary] |
| DRS | Transducer, Blood-Pressure, Extravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-17 |
| Device Publish Date | 2019-07-09 |
| 00690103217124 - HemoSphere Vita | 2024-03-05 PRESSURE CONTROLLER KIT |
| 00690103218848 - HemoSphere Vita | 2024-03-05 VitaWave Module |
| 00690103218855 - HemoSphere Vita | 2024-03-05 HemoSphere Vita Monitor |
| 00690103218862 - HemoSphere Vita | 2024-03-05 Vita Technology Module |
| 50690103218898 - VitaWave | 2024-02-28 VitaWave Finger Cuff Adult |
| 00690103217483 - EVOQUE | 2024-02-15 Edwards EVOQUE Stabilizer Plate |
| 00690103217490 - EVOQUE | 2024-02-15 Edwards EVOQUE Loading System |
| 00690103217506 - EVOQUE | 2024-02-15 Edwards EVOQUE Dilator Kit (24, 28, 33 Fr dilators) |