| Primary Device ID | 00851074007262 |
| NIH Device Record Key | 97ca8164-8a94-4b6c-b30c-db06095dde1e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HeartcoR |
| Version Model Number | Sentinel |
| Catalog Number | RX93030-005 |
| Company DUNS | 080555401 |
| Company Name | DATRIX LLC |
| 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 | 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 |
| Phone | 760 480-8874 |
| tbrewer@datrixmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851074007262 [Primary] |
| MWJ | Electrocardiograph,Ambulatory(Without Analysis) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2017-06-16 |
| 00851074007385 - CardioLabs | 2019-11-08 ECG Recorder (Event) |
| 00851074007392 - TLC Diagnostics | 2019-11-08 ECG recorder |
| 00851074007361 - Datrix | 2019-11-08 ECG Recorder |
| 00851074007002 - Sirona | 2019-11-08 ECG Recorder |
| 00851074007019 - VX3+ | 2019-11-08 Holter Recorder |
| 00851074007026 - VX3+ | 2019-11-08 Holter Recorder |
| 00851074007033 - BodyGuardian | 2019-11-08 Holter Recorder |
| 00851074007040 - CardioHolter | 2019-11-08 Holter Recorder |