Merge Hemo Link Assembly

GUDID 00842000100515

Merge Hemo 77-00327-00 Link Assembly

MERGE HEALTHCARE SOLUTIONS INC.

Cardiac catheterization laboratory computer

• Primary Device ID: 00842000100515
• NIH Device Record Key: cbf03b89-9b14-4564-a16a-4881899bc683
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merge Hemo Link Assembly
• Version Model Number: 77-00327-00
• Company DUNS: 065626069
• Company Name: MERGE HEALTHCARE SOLUTIONS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842000100515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082421

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: 2019-07-05
• Device Publish Date: 2019-06-27

Devices Manufactured by MERGE HEALTHCARE SOLUTIONS INC.

• 00842000101079 - Merge Hemo: 2024-09-18
• 00842000101154 - Merge PACS: 2024-07-09
• 00842000101161 - Merge Universal Viewer: 2024-05-08
• 00842000101123 - Merge Cardio: 2024-02-13 Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management syste
• 00842000101147 - Merge PACS: 2023-12-06
• 00842000101086 - Merge PACS: 2023-09-22
• 00842000101130 - Merge Universal Viewer: 2023-09-07
• 00842000100904 - Merge OrthoTemplates: 2023-06-19 Software implant template