| Primary Device ID | 00812324000044 |
| NIH Device Record Key | 18162933-d85a-4567-960f-00dfd32d36bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HeartCheck CardiBeat |
| Version Model Number | HC-WC-01 |
| Catalog Number | HC-WC-01 |
| Company DUNS | 251043907 |
| Company Name | CardioComm Solutions, Inc |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812324000044 [Primary] |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-12 |
| Device Publish Date | 2019-03-04 |
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| 00812324000242 - GEMS Win AutoAttendant | 2023-11-17 GEMS Win AutoAttendant |
| 00812324000259 - GEMS Win Air | 2023-11-17 GEMS Win Air |
| 00812324000228 - GEMS Win TTM & ICD | 2023-11-16 GEMS Win ARR TTM & Full Pacing |
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| 00812324000044 - HeartCheck CardiBeat | 2019-03-12HeartCheck CardiBeat portable ECG monitor |
| 00812324000044 - HeartCheck CardiBeat | 2019-03-12 HeartCheck CardiBeat portable ECG monitor |