Premier Heart MCG Analysis API

GUDID B320MCGS0

MCG Analysis API (Dedicated Server or Software-as-a-Service)

PREMIER HEART, LLC

Cardiac electrophysiology processing software

• Primary Device ID: B320MCGS0
• NIH Device Record Key: ecf0cfdf-40e8-44c4-bc3d-2f1c7869423a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premier Heart MCG Analysis API
• Version Model Number: MCGS
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B320MCGS0 [Primary]

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-13
• Device Publish Date: 2024-05-03

Devices Manufactured by PREMIER HEART, LLC

• 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: 2024-05-13MCG Analysis API (Dedicated Server or Software-as-a-Service)
• 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: 2018-06-18 Premier Heart MCG 12 Lead capture hardware.
• B320CF190 - Premier Heart MCG: 2018-03-29 Premier Heart MCG Model CF19