ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm

GUDID 00860013616823

v3.0.0

Anumana, Inc.

Cardiopulmonary physiological parameter analysis software, professional-only

• Primary Device ID: 00860013616823
• NIH Device Record Key: 8ce850d4-1bd9-4d38-b07b-64fbcdeb7f40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm
• Version Model Number: 1010
• Company DUNS: 118190277
• Company Name: Anumana, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013616823 [Primary]

FDA Product Code

• QYE: Reduced Ejection Fraction Machine Learning-Based Notification Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-30
• Device Publish Date: 2026-03-20

On-Brand Devices [ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm]

• 00860007426445: v 2.3.0 (1010)
• 00860013616823: v3.0.0