Acumen IQ Sensor with Fluid Meter

Basic Information

• Brand Name: Acumen IQ Sensor with Fluid Meter
• Primary DI: 00690103205763
• Version / Model: AIQSFM65
• Catalog Number: AIQSFM65
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-10
• Public Version: 1
• Public Version Date: 2025-07-18
• Public Version Status: New
• Public Device Record Key: b26e173a-3fc3-41d7-983d-6d96241ef2d9

Device Description

ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER 5-PACK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQK	Computer, Diagnostic, Programmable	Cardiovascular	870.1425	2
QMS	Adjunctive Open Loop Fluid Therapy Recommender	Cardiovascular	870.5600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67511	Intravenous line sensor, gravity infusion	A noninvasive electronic device intended to be fitted within a gravity-fed intravenous (IV) line to detect flow rate of fluids being administered to a patient. It has a Luer connection at each end and in intended for electrical connection to receive power from, and send data to, a hemodynamic patient monitor. Flow rate is determined by microthermal measurement principle technology. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50690103205768	GS1	Case	5	In Commercial Distribution
Primary	00690103205763	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place.