Change Healthcare Cardiology ECG Management

GUDID 17540262110128

Change Healthcare Canada Company

Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer

• Primary Device ID: 17540262110128
• NIH Device Record Key: 22bc1987-7c6a-49c2-a6cb-f90e642c0136
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Change Healthcare Cardiology ECG Management
• Version Model Number: 15.1
• 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	17540262110128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113515

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: 2024-02-16
• Device Publish Date: 2024-02-08

On-Brand Devices [Change Healthcare Cardiology ECG Management ]

• 17540262110043: 14.3
• 17540262110050: 14.3.2
• 17540262110098: 15.0
• 17540262110104: 15.0.1
• 17540262110036: 14.2
• 17540262110128: 15.1