Matrix Wearable 009-400-0193

GUDID 00815187020587

M5 Recorder, 2-Lead Patient Cable AHA, System Kit 00815187020556; M5 Recorder 00815187020440; M5 2-Lead Patient Cable AHA 00815187020549; M5 USB Cable 1-Meter

GLOBAL INSTRUMENTATION, LLC

Electrocardiographic ambulatory recorder
Primary Device ID00815187020587
NIH Device Record Key9e1ed714-7aca-4782-a633-082df915f5a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMatrix Wearable
Version Model Number009-400-0193
Catalog Number009-400-0193
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 Batchtrue
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
GS100815187020587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSHRecorder, Magnetic Tape, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-09
Device Publish Date2024-04-01

On-Brand Devices [Matrix Wearable]

00815187020600M5 Recorder, 4-Lead Patient Cable (RL lead) AHA Kit 00815187020556; M5 Recorder 00815187020471;
00815187020563M5 Recorder, USB Cable, USB Charger, Kit 00815187020556; M5 Recorder 00815187020549; M5 USB Cabl
00815187020556M5 Recorder
00815187020549M5 USB Cable (1-Meter)
00815187020471M5 4-Lead Patient Cable - RL (AHA)
00815187020433M5 2-Lead Patch
00815187020570M5 Neck Lanyard
00815187020594M5 Recorder, 3-Lead Patient Cable AHA, System Kit 00815187020556; M5 Recorder 00815187020457; M5
00815187020587M5 Recorder, 2-Lead Patient Cable AHA, System Kit 00815187020556; M5 Recorder 00815187020440; M5
00815187020457M5 3-Lead Patient Cable AHA
00815187020440M5 2-Lead Patient Cable AHA
00815187020112M5 Patient Cable Cradle
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