Samsung ECG Monitor Application

GUDID 08806090792021

Samsung Electronics Co., Ltd.

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• Primary Device ID: 08806090792021
• NIH Device Record Key: 6b684bc7-f193-4557-9514-664cdfba8c53
• Commercial Distribution Discontinuation: 2020-09-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Samsung ECG Monitor Application
• Version Model Number: 1.1
• Company DUNS: 687967554
• Company Name: Samsung Electronics Co., Ltd.
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806090792021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201168

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-02
• Device Publish Date: 2020-09-24

On-Brand Devices [Samsung ECG Monitor Application ]

• 08806090792045: 1.1
• 08806090792021: 1.1