M12 System 000-400-0129

GUDID 00815187020754

SD Card (GI Label)

GLOBAL INSTRUMENTATION, LLC

Electrocardiographic ambulatory recorder
Primary Device ID00815187020754
NIH Device Record Keyc0933f61-8de3-4806-891a-3a12485d8d3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameM12 System
Version Model Number000-400-0129
Catalog Number000-400-0129
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815187020754 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-11
Device Publish Date2024-12-03

Devices Manufactured by GLOBAL INSTRUMENTATION, LLC

00815187020754 - M12 System2024-12-11SD Card (GI Label)
00815187020754 - M12 System2024-12-11 SD Card (GI Label)
00815187020112 - Matrix Wearable2024-04-09 M5 Patient Cable Cradle
00815187020440 - Matrix Wearable2024-04-09 M5 2-Lead Patient Cable AHA
00815187020457 - Matrix Wearable2024-04-09 M5 3-Lead Patient Cable AHA
00815187020587 - Matrix Wearable2024-04-09 M5 Recorder, 2-Lead Patient Cable AHA, System Kit 00815187020556; M5 Recorder 00815187020440; M5 2-Lead Patient Cable AHA 008151
00815187020594 - Matrix Wearable2024-04-09 M5 Recorder, 3-Lead Patient Cable AHA, System Kit 00815187020556; M5 Recorder 00815187020457; M5 3-Lead Patient Cable AHA 008151
90815187020696 - Matrix Holter System2022-05-09 M12R Recorder, 10-Lead Cable AHA, System Kit 90815187020191; M12R, 10 Lead Patient Cable 90815187020252; M12R Holter Recorder 90
90815187020702 - Matrix Holter System2022-05-09 M12R Recorder, 7-Lead Cable AHA, System Kit 90815187020153; M12R, 7 Lead patient Cable (AHA) 90815187020252; M12R Holter Recorde
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