cvi42

GUDID 00882916000011

Circle Cardiovascular Imaging Inc

MRI system application software

• Primary Device ID: 00882916000011
• NIH Device Record Key: ec8831be-700c-4469-bbd8-16d79565f1da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cvi42
• Version Model Number: 5.x
• Company DUNS: 248028578
• Company Name: Circle Cardiovascular Imaging Inc
• 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: false
• Serial Number: true
• 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	00882916000011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082628

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: 2019-05-14
• Device Publish Date: 2019-05-06

On-Brand Devices [cvi42]

• 00088291600001: Cardiac MR & CT imaging software application
• 00882916000011: 5.x
• 00882916000004: Cardiac MR & CT imaging software application
• 00882916000028: 6.x