Merge Unity PACS

GUDID 00842000100331

Standalone software application

MERGE HEALTHCARE SOLUTIONS INC.

Radiology PACS software

• Primary Device ID: 00842000100331
• NIH Device Record Key: 54533047-52ee-491b-8e0c-751b68c712f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merge Unity PACS
• Version Model Number: 11.2
• 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	00842000100331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041935

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-23
• Device Publish Date: 2017-11-30

On-Brand Devices [Merge Unity PACS]

• 00842000100744: 12.0
• 00842000100331: Standalone software application
• 00842000100058: Standalone software application
• 00842000100461: 11.0
• 00842000100829: 13.0