Merge Hemo

GUDID 00842000100447

MERGE HEALTHCARE SOLUTIONS INC.

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• Primary Device ID: 00842000100447
• NIH Device Record Key: 58250c79-ad78-4741-9ee0-16c3e71f595f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merge Hemo
• Version Model Number: 11.0
• 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	00842000100447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152864

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

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 Hemo]

• 00842000100034: 10.1
• 00842000100010: 10.0.4
• 00842000100430: 10.2
• 00842000100874: 10.3
• 00842000100966: 10.4
• 00842000100447: 11.0
• 00842000100027: 9.4