| Primary Device ID | B210AC0090 |
| NIH Device Record Key | 75aa5916-42d0-4689-9034-8ba00824921d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kardia Mobile |
| Version Model Number | AC-009 |
| Company DUNS | 078523613 |
| Company Name | ALIVECOR, 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 | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B210AC0090 [Primary] |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
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| B210AC0110 - KardiaBand System | 2024-04-01 The Kardia Band System is a trans-telephonic (transmission by telephone) ECG (electrocardiogram) event recorder that records, st |
| B210AC0210 - KardiaMobile Card | 2022-07-21 The AliveCor KardiaMobile Card System is a single-channel electrocardiogram (ECG) device that is intended to record, store, tran |
| B210AC0190 - KardiaMobile 6L | 2020-05-11 |
| B210AC0090 - Kardia Mobile | 2018-07-06 |
| B210AC0090 - Kardia Mobile | 2018-07-06 |