| Primary Device ID | 05903021560056 |
| NIH Device Record Key | 52731bad-098f-4ec0-8ce8-3af8c04d974a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PocketECG CRS - Medicalgorithmics Unified Cardiac |
| Version Model Number | Type: PECGT-IIIR |
| Company DUNS | 522657576 |
| Company Name | MEDICALGORITHMICS S A |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | 05903021560056 [Primary] |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-21 |
| Device Publish Date | 2018-08-21 |
| 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 |