Change Healthcare Cardiology Hemodynamics

GUDID 17540262170030

Change Healthcare Canada Company

Cardiac catheterization laboratory computer

• Primary Device ID: 17540262170030
• NIH Device Record Key: 68b5deb2-ae26-497b-95bd-986f5d6b5c7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Change Healthcare Cardiology Hemodynamics
• Version Model Number: 15.1.1
• Company DUNS: 246576391
• Company Name: Change Healthcare Canada Company
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	17540262170030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230881

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: 2025-02-18
• Device Publish Date: 2025-02-10

On-Brand Devices [Change Healthcare Cardiology Hemodynamics]

• 17540262170016: 15.0.1
• 17540262170023: 15.1
• 17540262170030: 15.1.1