Matrix Holter System 005-400-0068

GUDID 90815187020399

M12A Enterprise System Software

GLOBAL INSTRUMENTATION, LLC

Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder

• Primary Device ID: 90815187020399
• NIH Device Record Key: d6f4ccf0-8750-416a-8754-32e1c2d15243
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Matrix Holter System
• Version Model Number: M12A
• Catalog Number: 005-400-0068
• Company DUNS: 147035427
• Company Name: GLOBAL INSTRUMENTATION, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	90815187020399 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051730

FDA Product Code

• MLO: Electrocardiograph, Ambulatory, With Analysis Algorithm

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-03-22

On-Brand Devices [Matrix Holter System]

• 90815187020399: M12A Enterprise System Software
• 90815187020382: M12A Office System Software
• 90815187020719: M12R L Recorder, 10-Lead Cable, AHA, System Kit 90815187020184; M12R, 10 Lead patient Cable (DIN
• 90815187020702: M12R Recorder, 7-Lead Cable AHA, System Kit 90815187020153; M12R, 7 Lead patient Cable (AHA) 908
• 90815187020696: M12R Recorder, 10-Lead Cable AHA, System Kit 90815187020191; M12R, 10 Lead Patient Cable 9081518