Merge Hemo

GUDID 00842000101079

MERGE HEALTHCARE SOLUTIONS INC.

Patient monitoring system module, multifunction

• Primary Device ID: 00842000101079
• NIH Device Record Key: c683f55c-444b-457d-b819-4acb0f123342
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merge Hemo
• Version Model Number: RCSV2
• Company DUNS: 065626069
• Company Name: MERGE HEALTHCARE SOLUTIONS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	00842000101079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233326

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: 2024-09-18
• Device Publish Date: 2024-09-10

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
• 00842000101079: RCSV2