FDA.reportPublic FDA data

Premier Heart MCG Model VH12

Primary DI
B320VH120
Brand
Premier Heart MCG Model VH12
Company
PREMIER HEART, LLC
Model
VH12
Device description
Premier Heart MCG 12 Lead capture hardware.
Published
2018-05-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B320VH120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel). It may be intended for use while the patient is at rest (rest ECG) and/or during physical exercise (stress/exercise ECG), and may include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5168833383support@premierheart.com

Regulatory Flags#

DUNS number
109797584
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B320MCGS0Premier Heart MCG Analysis APIMCGS2024-05-03
B320CF190Premier Heart MCGCF19CF192016-09-27
B320MCGC0Premier Heart MCG Analysis SoftwareMCGC2018-05-17
B320LCA00Premier Heart Reusable Limb Clip ElectrodesLCA02024-05-06
B320LCA10Premier Heart Reusable Limb Clip ElectrodesLCA12024-05-06
B320LCA20Premier Heart Reusable Limb Clip ElectrodesLCA22024-05-06

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Primary DI, Brand, Company table
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08800069700277AT-PatchATsens Co., Ltd.DQK2025-11-05
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27540279250142CardioSTATIcentia Inc.DQK2024-12-18
G637CEA0Cardiologs PlatformPHILIPS FRANCEDQK2024-09-23
17540279105018EARTIcentia Inc.DQK2024-03-26
17540279200072CardioSTATIcentia Inc.DQK2024-03-26
17540279200140CardioSTATIcentia Inc.DQK2024-03-26
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