Pouch 704554

GUDID 90815187020320

HR300/HR1200/M3R/M12R Carrying Case and Strap

GLOBAL INSTRUMENTATION, LLC

Electrocardiographic ambulatory recorder

• Primary Device ID: 90815187020320
• NIH Device Record Key: 54725859-754a-479a-b553-3dd955a96cba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pouch
• Version Model Number: 001-400-0027
• Catalog Number: 704554
• 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: false
• 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	90815187020320 [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 [Pouch]

• 90815187020320: HR300/HR1200/M3R/M12R Carrying Case and Strap
• 90815187020313: HR100 Carrying Case and Strap