GI Holter System 001-400-0064

GUDID 90815187020252

M12R Holter Recorder

GLOBAL INSTRUMENTATION, LLC

Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder

• Primary Device ID: 90815187020252
• NIH Device Record Key: f9d81655-7488-4436-85f0-21311bda506d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GI Holter System
• Version Model Number: M12R
• Catalog Number: 001-400-0064
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	90815187020252 [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: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-10-21

On-Brand Devices [GI Holter System]

• 90815187020429: M3R Intermittent and Continuous ECG Recorder
• 90815187020375: M3R Holter Recorder
• 90815187020269: M12R L Holter Recorder
• 90815187020252: M12R Holter Recorder
• 90815187020245: M3R L Holter Recorder