Total ECG GMD50610001

GUDID 00850033167177

ECG device incorporating a wireless 12-Lead ECG system, Windows®-based CardioVu software using the Glasgow 12-lead ECG analysis program, and a compact ECG acquisition device.

GLOBALMEDIA GROUP, LLC

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• Primary Device ID: 00850033167177
• NIH Device Record Key: 86c6e715-0870-4cda-822a-595c8713e60b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Total ECG
• Version Model Number: GMD50610001
• Catalog Number: GMD50610001
• Company DUNS: 103201849
• Company Name: GLOBALMEDIA GROUP, 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: true
• 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	00850033167177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181658

FDA Product Code

• DSI: Detector And Alarm, Arrhythmia

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: 2023-12-18
• Device Publish Date: 2023-12-08

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• 00850033167177 - Total ECG: 2023-12-18ECG device incorporating a wireless 12-Lead ECG system, Windows®-based CardioVu software using the Glasgow 12-lead ECG analysis program, and a compact ECG acquisition device.
• 00850033167177 - Total ECG: 2023-12-18 ECG device incorporating a wireless 12-Lead ECG system, Windows®-based CardioVu software using the Glasgow 12-lead ECG analysis