| Primary Device ID | B320MCGC0 |
| NIH Device Record Key | 2f3ae87b-6a98-4d7a-b706-010315d62194 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premier Heart MCG Analysis Software |
| Version Model Number | MCGC |
| Company DUNS | 109797584 |
| Company Name | PREMIER HEART, 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 | false |
| 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 | B320MCGC0 [Primary] |
| DQK | Computer, Diagnostic, Programmable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-06-18 |
| Device Publish Date | 2018-05-17 |
| B320LCA00 - Premier Heart Reusable Limb Clip Electrodes | 2024-05-14 Reusable Limb Clip Electrodes, Large, Universal Lead Colors |
| B320LCA10 - Premier Heart Reusable Limb Clip Electrodes | 2024-05-14 Reusable Limb Clip Electrodes, Large, US/AHA Lead Colors |
| B320LCA20 - Premier Heart Reusable Limb Clip Electrodes | 2024-05-14 Reusable Limb Clip Electrodes, Large, EU/IEC Lead Colors |
| B320MCGS0 - Premier Heart MCG Analysis API | 2024-05-13 MCG Analysis API (Dedicated Server or Software-as-a-Service) |
| B320MCGC0 - Premier Heart MCG Analysis Software | 2018-06-18Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client (reference implementation and API) - MCG Webapps/Report Generator |
| B320MCGC0 - Premier Heart MCG Analysis Software | 2018-06-18 Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client (reference implementation and API) - MCG Webap |
| B320VH120 - Premier Heart MCG Model VH12 | 2018-06-18 Premier Heart MCG 12 Lead capture hardware. |
| B320CF190 - Premier Heart MCG | 2018-03-29 Premier Heart MCG Model CF19 |