Garmin ECG App

GUDID 00860009117709

Garmin International, Inc.

Cardiac electrophysiology processing software

• Primary Device ID: 00860009117709
• NIH Device Record Key: 8ab1f8eb-7a8a-4a0c-92c3-f3268cb17926
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Garmin ECG App
• Version Model Number: 1.x
• Company DUNS: 791288004
• Company Name: Garmin International, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009117709 [Primary]

FDA Product Code

• QDA: Electrocardiograph Software For Over-The-Counter Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-12-18
• Device Publish Date: 2023-01-24

On-Brand Devices [Garmin ECG App]

• 00860009117716: 1.x
• 00860009117709: 1.x