EGG-AF

GUDID 00860011843603

Tempus 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.

Tempus AI, Inc.

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

Customer Support Contacts

• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com
• Phone: 800-739-4137
• Email: support@tempus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011843603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233549

FDA Product Code

• SBQ: Atrial Fibrillation Risk Prediction 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: 2024-09-12
• Device Publish Date: 2024-09-04