| Primary Device ID | 05903021560131 |
| NIH Device Record Key | b1f49c65-d9f2-4599-bc04-78d4f5a26b4b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DeepRhythmAI |
| Version Model Number | Type: DRAI |
| Company DUNS | 522657576 |
| Company Name | MEDICALGORITHMICS S A |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 05903021560131 [Primary] |
| DQK | Computer, Diagnostic, Programmable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-15 |
| Device Publish Date | 2022-08-05 |
| 05903021560131 - DeepRhythmAI | 2022-08-15The DeepRhythmAI (DRAI) is a cloud-based software for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration. The main component of DeepRhythmAI is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review. DeepRhythmAI can be integrated into medical devices. |
| 05903021560131 - DeepRhythmAI | 2022-08-15 The DeepRhythmAI (DRAI) is a cloud-based software for automated analysis of ECG data. It uses a scalable Application Programming |
| 05903021560124 - Q Patch | 2022-07-01 The Q Patch is a single channel ECG recorder. The device is intended to be placed on the sternum (in the middle of the chest). T |
| 05903021560155 - Q Patch Mobile Application | 2022-07-01 Q Patch Mobile Application (Mobile application) – The Q Patch Mobile Application is intended to be used for interacting with t |
| 05903021560162 - Q Patch Downloader | 2022-07-01 Q Patch Downloader (PC application) – The intended use of the Q Patch Downloader application is to download the data from comp |
| 05903021560070 - PocketECG IV – Unified Arrhythmia Diagnostic System | 2020-08-24 The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic System and is intended to: acquire, |
| 05903021560087 - PocketECG IV – Unified Arrhythmia Diagnostic System | 2020-08-24 The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic System and is intended to: acquire, |
| 05903021560094 - PocketECG IV – Unified Arrhythmia Diagnostic System | 2020-08-24 The battery type P4BA-AA-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic System. The battery is intended |
| 05903021560100 - PocketECG IV – Unified Arrhythmia Diagnostic System | 2020-08-24 The battery charger type P3CH-AB-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic System. The charger is |