AccessGUDID - DEVICE: Acumen IQ Sensor with Fluid Meter (00690103205800)

GUDID

Device Identifier (DI) Information

Brand Name: Acumen IQ Sensor with Fluid Meter
Version or Model: AIQSFM85
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AIQSFM85
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103205800
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 84'' / 213CM 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?
11010	Electronic gravity infusion controller	An electrically-powered device intended to be used to control and monitor the gravity infusion of intravenous (IV) fluids, providing an alarm (visible/audible) when pre-set limits are exceeded. It is available in two main configurations: 1) a device with an electronic flow sensor (drop counter) that monitors/measures the amount of fluid that passes through the infusion line; or 2) a device that measures the weight of the fluid container and may assist in bolus administration. The predetermined values may be selected by the user, and the device may display flow rate, total volume, and may record data. Some types can be used during arthroscopic procedures.	Obsolete	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: b41e0681-e6a3-4709-940b-390f9a37a0b9
Public Version Date: August 07, 2023
Public Version Number: 1
DI Record Publish Date: July 28, 2023