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 |
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 |