| Primary Device ID | B147HT20 |
| NIH Device Record Key | 610e4e26-e9b0-4ff8-860f-92220ffd2aba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Heartrak 2 |
| Version Model Number | Heartrak 2 |
| Company DUNS | 803593073 |
| Company Name | UNIVERSAL MEDICAL, 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B147HT20 [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 | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-01-21 |
| B14731161 - Pacetrak Plus rev 3 | 2018-03-29 Transmitters and Receivers, Electrocardiograph, Telephone |
| B147CA0 - Cardiostation® Advantage Software | 2018-03-29 Cardiostation Software sold with TTM module. |
| B147CBECAT0 - Heartrak ECAT Patient Cable | 2018-03-29 Electrode cable |
| B147CSS0 - Cardiostation Premier Stand Alone Software | 2018-03-29 Cardiostation Software sold with wireless devices. |
| B147CSTTM010 - Cardiostation Transtelephonic Module | 2018-03-29 Transmitters and Receivers, Electrocardiograph, Telephone |
| B147EC0 - eCardiostation Software | 2018-03-29 Software with CardioStation |
| B147FSAIR0 - Fusion Air | 2018-03-29 Transmitters and Receivers, Electrocardiograph, Telephone |
| B147HT20 - Heartrak 2 | 2018-03-29Telephone electrocardiograph transmitter and receiver |
| B147HT20 - Heartrak 2 | 2018-03-29 Telephone electrocardiograph transmitter and receiver |