Change Healthcare Mammography Plus

GUDID 17540262180046

Change Healthcare Canada Company

Radiological PACS software

• Primary Device ID: 17540262180046
• NIH Device Record Key: 3de53f9e-3fd4-4c61-b4b1-a2e5ac8043bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Change Healthcare Mammography Plus
• Version Model Number: 14.2.1
• Company DUNS: 246576391
• Company Name: Change Healthcare Canada Company
• 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: 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	17540262180046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142850

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2023-11-20
• Device Publish Date: 2023-11-10

On-Brand Devices [Change Healthcare Mammography Plus]

• 17540262180039: 14.2
• 17540262180022: 14.1
• 17540262180015: 14.0
• 17540262180046: 14.2.1