| Primary Device ID | 00860011843610 |
| NIH Device Record Key | 24bef610-44f8-4970-bb5e-e8fdd5effdc4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tempus ECG-Low EF |
| Version Model Number | 2 |
| 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 | true |
| 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 |
| Phone | 800-739-4137 |
| support@tempus.com | |
| Phone | 800-739-4137 |
| support@tempus.com | |
| Phone | 800-739-4137 |
| support@tempus.com | |
| Phone | 800-739-4137 |
| support@tempus.com | |
| Phone | 800-739-4137 |
| support@tempus.com | |
| Phone | 800-739-4137 |
| support@tempus.com | |
| Phone | 800-739-4137 |
| support@tempus.com | |
| Phone | 800-739-4137 |
| support@tempus.com | |
| Phone | 800-739-4137 |
| support@tempus.com | |
| Phone | 800-739-4137 |
| support@tempus.com | |
| Phone | 800-739-4137 |
| support@tempus.com | |
| Phone | 800-739-4137 |
| support@tempus.com | |
| Phone | 800-739-4137 |
| support@tempus.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860011843610 [Primary] |
| QYE | Reduced Ejection Fraction Machine Learning-Based Notification Software |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-01 |
| Device Publish Date | 2025-07-24 |
| 00860011843610 - Tempus ECG-Low EF | 2025-08-01Tempus ECG-Low EF is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%). It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients 40 years of age or older at risk of heart failure. This population includes but is not limited to patients with atrial fibrillation, aortic stenosis, cardiomyopathy, myocardial infarction, diabetes, hypertension, mitral regurgitation, and ischemic heart disease. Tempus ECG-Low EF only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-Low EF is not intended to be a stand-alone diagnostic tool for cardiac conditions, should not be used for patient monitoring, and should not be used on ECGs with paced rhythms. Results should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history. A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of low LVEF. Patients receiving a negative result should continue to be evaluated in accordance with current medical practice standards using all available clinical information. |
| 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 | 2024-09-12 Tempus ECG-AF is a cardiovascular machine learning-based notification software intended to analyze recordings of 12-lead ECG dev |