Merge Cardio

GUDID 00842000100928

Standalone software application

MERGE HEALTHCARE SOLUTIONS INC.

Radiology PACS software

• Primary Device ID: 00842000100928
• NIH Device Record Key: a4e892e2-12f2-4785-be96-c3a1fcb8ee6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merge Cardio
• Version Model Number: 12.1
• Company DUNS: 065626069
• Company Name: MERGE HEALTHCARE SOLUTIONS INC.
• 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: true
• 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	00842000100928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051649

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2021-09-29
• Device Publish Date: 2021-09-21

On-Brand Devices [Merge Cardio]

• 00842000100591: Standalone software application
• 00842000100416: Standalone software application
• 00842000100041: Standalone software application.
• 00842000100768: 12.0.1
• 00842000100928: Standalone software application
• 00842000101123: Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascu