AccessGUDID - DEVICE: Acumen IQ Sensor with Fluid Meter (00690103205763)

GUDID

Device Identifier (DI) Information

Brand Name: Acumen IQ Sensor with Fluid Meter
Version or Model: AIQSFM65
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AIQSFM65
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103205763
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQK	Computer, Diagnostic, Programmable
QMS	Adjunctive Open Loop Fluid Therapy Recommender

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry place.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b26e173a-3fc3-41d7-983d-6d96241ef2d9
Public Version Date: July 18, 2025
Public Version Number: 1
DI Record Publish Date: July 10, 2025