Conserus Enterprise Viewer

GUDID 17540262040029

Change Healthcare Canada Company

Radiology picture archiving and communication system application software

• Primary Device ID: 17540262040029
• NIH Device Record Key: 0ab0e657-dfa2-4bc1-8c58-70aae958f3da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Conserus Enterprise Viewer
• Version Model Number: 2.2.0
• 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	17540262040029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161130

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: 2019-04-08
• Device Publish Date: 2019-03-29

On-Brand Devices [Conserus Enterprise Viewer]

• 17540262040012: 2.1
• 17540262040029: 2.2.0