| Primary Device ID | B320VH120 | 
| NIH Device Record Key | 775b3de5-d2c3-4195-bfe9-c813d500c9f1 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Premier Heart MCG Model VH12 | 
| Version Model Number | VH12 | 
| 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 | 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 | 
| Phone | 5168833383 | 
| support@premierheart.com | |
| Phone | 5168833383 | 
| support@premierheart.com | |
| Phone | 5168833383 | 
| support@premierheart.com | |
| Phone | 5168833383 | 
| support@premierheart.com | |
| Phone | 5168833383 | 
| support@premierheart.com | |
| Phone | 5168833383 | 
| support@premierheart.com | |
| Phone | 5168833383 | 
| support@premierheart.com | |
| Phone | 5168833383 | 
| support@premierheart.com | |
| Phone | 5168833383 | 
| support@premierheart.com | |
| Phone | 5168833383 | 
| support@premierheart.com | |
| Phone | 5168833383 | 
| support@premierheart.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | B320VH120 [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 | 2018-05-16 | 
| 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 | 2018-06-18 Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client (reference implementation and API) - MCG Webap | 
| B320VH120 - Premier Heart MCG Model VH12 | 2018-06-18Premier Heart MCG 12 Lead capture hardware. | 
| 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 |