Identity
- Trade Name
- EGG-AF FDA UDI
- Generic Name
- Cardiopulmonary physiological parameter analysis software FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 3 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860011843603 FDA UDI
- 510(k) Number
- K233549 FDA UDI
- FDA Product Code
- SBQ FDA UDI
- GMDN Term
- Cardiopulmonary physiological parameter analysis software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2380 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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Single Use
No
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Implantable
No
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Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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Convenience Kit
No
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Combination Product
No
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HCT/P
No
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Premarket Exempt
No
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Lot / Batch Number
Yes
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Serial Number
No
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Expiration Date
No
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Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary physiological parameter analysis software
Egg-Af by Tempus AI, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tempus AI, Inc.
Sources (1)
- FDA UDI 238af2e6-82b8-44a4-80bf-77da8afc9eda 35 fields · synced Jun 8, 2026