Premier Heart MCG Model VH12

GUDID B320VH120

Premier Heart MCG 12 Lead capture hardware.

PREMIER HEART, LLC

Electrocardiograph, professional, multichannel
Primary Device IDB320VH120
NIH Device Record Key775b3de5-d2c3-4195-bfe9-c813d500c9f1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremier Heart MCG Model VH12
Version Model NumberVH12
Company DUNS109797584
Company NamePREMIER HEART, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5168833383
Emailsupport@premierheart.com
Phone5168833383
Emailsupport@premierheart.com
Phone5168833383
Emailsupport@premierheart.com
Phone5168833383
Emailsupport@premierheart.com
Phone5168833383
Emailsupport@premierheart.com
Phone5168833383
Emailsupport@premierheart.com
Phone5168833383
Emailsupport@premierheart.com
Phone5168833383
Emailsupport@premierheart.com
Phone5168833383
Emailsupport@premierheart.com
Phone5168833383
Emailsupport@premierheart.com
Phone5168833383
Emailsupport@premierheart.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB320VH120 [Primary]

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-06-18
Device Publish Date2018-05-16

Devices Manufactured by PREMIER HEART, LLC

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B320LCA20 - Premier Heart Reusable Limb Clip Electrodes2024-05-14 Reusable Limb Clip Electrodes, Large, EU/IEC Lead Colors
B320MCGS0 - Premier Heart MCG Analysis API2024-05-13 MCG Analysis API (Dedicated Server or Software-as-a-Service)
B320MCGC0 - Premier Heart MCG Analysis Software2018-06-18 Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client (reference implementation and API) - MCG Webap
B320VH120 - Premier Heart MCG Model VH122018-06-18Premier Heart MCG 12 Lead capture hardware.
B320VH120 - Premier Heart MCG Model VH122018-06-18 Premier Heart MCG 12 Lead capture hardware.
B320CF190 - Premier Heart MCG2018-03-29 Premier Heart MCG Model CF19

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