AccessGUDID - DEVICE: ELEFT (Eko Low Ejection Fraction Tool) (00850010298146)

GUDID

Device Identifier (DI) Information

Brand Name: ELEFT (Eko Low Ejection Fraction Tool)
Version or Model: v7.x
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ELEFT
Company Name: Eko Devices, Inc.

Primary DI Number: 00850010298146
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079670921 *Terms of Use

Device Description: Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
47699	Cardiopulmonary physiological parameter analysis software	A software program designed to add image processing and/or data analysis capabilities to a computer/workstation for the interpretation and/or screening of cardiopulmonary physiological parameters [e.g., electrocardiogram (ECG), blood pressure, vital capacity (VC)]; data may be uploaded, or collected in real-time by connection (e.g., wired, Bluetooth) to other devices for spot-checks and/or continuous monitoring. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiopulmonary events [e.g., acute myocardial infarction (AMI)] or screen for specific conditions (e.g., low ejection fraction). It might include machine learning (ML) technology.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QYE	Reduced Ejection Fraction Machine Learning-Based Notification Software

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233409	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d18fd172-b9ae-4813-8c93-c54cc68b11d9
Public Version Date: March 25, 2025
Public Version Number: 1
DI Record Publish Date: March 17, 2025