EGG-AF

GUDID 00860011843603

Cardiac electrophysiology processing software

Primary Device ID	00860011843603
NIH Device Record Key	238af2e6-82b8-44a4-80bf-77da8afc9eda
Commercial Distribution Status	In Commercial Distribution
Brand Name	EGG-AF
Version Model Number	3
Company DUNS	080037051
Company Name	Tempus AI, 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	false
Serial Number	false
Manufacturing Date	false
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 Issuing Agency	Device ID
GS1	00860011843603 [Primary]

SBQ	Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software

Steralize Prior To Use	false
Device Is Sterile	false

00860011843610 - Tempus ECG-Low EF	2025-08-01 Tempus ECG-Low EF is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated wit
00860011843603 - EGG-AF	2024-09-12Tempus ECG-AF is a cardiovascular machine learning-based notification software intended to analyze recordings of 12-lead ECG devices from patients 65 years of age and older. The software employs machine learning techniques to analyze ECG recordings and detect signs associated with a patient experiencing atrial fibrillation and/or atrial flutter (collectively referred to as AF) within the next 12 months. The device is designed to extract otherwise unavailable information from ECGs conducted under the standard of care, to help health care providers better identify patients who may be at risk for undiagnosed AF in order to evaluate them for referral of further diagnostic follow up and address the unmet need of reducing the number of undiagnosed AF patients.
00860011843603 - EGG-AF	2024-09-12 Tempus ECG-AF is a cardiovascular machine learning-based notification software intended to analyze recordings of 12-lead ECG dev