Change Healthcare Enterprise Imaging Network Viewer

GUDID 17540262130027

Change Healthcare Canada Company

Radiology PACS software

• Primary Device ID: 17540262130027
• NIH Device Record Key: 21107e3a-3f0f-4eb5-b030-416d973e02ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Change Healthcare Enterprise Imaging Network Viewer
• Version Model Number: 1.0.1
• 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	17540262130027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181185

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: 2021-02-03
• Device Publish Date: 2021-01-26

On-Brand Devices [Change Healthcare Enterprise Imaging Network Viewer]

• 17540262130010: 1.0.0
• 17540262130027: 1.0.1
• 17540262130041: 1.0.3