GI Holter System 001-400-0064

GUDID 90815187020252

M12R Holter Recorder

GLOBAL INSTRUMENTATION, LLC

Electrocardiographic ambulatory recorder
Primary Device ID90815187020252
NIH Device Record Keyf9d81655-7488-4436-85f0-21311bda506d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGI Holter System
Version Model NumberM12R
Catalog Number001-400-0064
Company DUNS147035427
Company NameGLOBAL INSTRUMENTATION, 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS190815187020252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MLOElectrocardiograph, Ambulatory, With Analysis Algorithm

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2016-10-21

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90815187020245M3R L Holter Recorder

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