Merge Hemo

GUDID 00842000100027

MERGE HEALTHCARE SOLUTIONS INC.

Patient monitoring system module, multifunction Patient monitoring system module, multifunction Patient monitoring system module, multifunction Patient monitoring system module, multifunction Patient monitoring system module, multifunction Patient monitoring system module, multifunction Patient monitoring system module, multifunction Patient monitoring system module, multifunction Patient monitoring system module, multifunction Patient monitoring system module, multifunction Patient monitoring system module, multifunction Patient monitoring system module, multifunction

• Primary Device ID: 00842000100027
• NIH Device Record Key: 55bfdfca-b777-40d9-b119-32f6c8447f3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merge Hemo
• Version Model Number: 9.4
• 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	00842000100027 [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