| Primary Device ID | 50690103205768 |
| NIH Device Record Key | b26e173a-3fc3-41d7-983d-6d96241ef2d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acumen IQ Sensor with Fluid Meter |
| Version Model Number | AIQSFM65 |
| Catalog Number | AIQSFM65 |
| 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 | true |
| 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 | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00690103205763 [Primary] |
| GS1 | 50690103205768 [Package] Contains: 00690103205763 Package: Case [5 Units] In Commercial Distribution |
| DQK | Computer, Diagnostic, Programmable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-18 |
| Device Publish Date | 2025-07-10 |
| 50690103205805 | ACUMEN IQ SENSOR 84'' / 213CM WITH FLUID METER 5-PACK |
| 50690103205768 | ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER 5-PACK |