Merge Eye Care PACS

GUDID 00842000100584

Standalone software application

MERGE HEALTHCARE SOLUTIONS INC.

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• Primary Device ID: 00842000100584
• NIH Device Record Key: 4ecf4c20-51db-4c89-b542-e36980e1a1ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merge Eye Care PACS
• Version Model Number: 5.1.4
• 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	00842000100584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110006

FDA Product Code

• NFJ: System, Image Management, Ophthalmic

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: 2017-02-10

On-Brand Devices [Merge Eye Care PACS]

• 00842000100584: Standalone software application
• 00842000100553: Standalone software application
• 00842000100317: Standalone software application
• 00842000100096: Standalone software application