TruPlan

GUDID 00882916000516

Circle Cardiovascular Imaging Inc

CT system application software

• Primary Device ID: 00882916000516
• NIH Device Record Key: 398e5ac6-9c11-4115-b9b2-160328cbba47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruPlan
• Version Model Number: 1.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: 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	00882916000516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202212

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: 2021-03-09
• Device Publish Date: 2021-03-01

On-Brand Devices [TruPlan]

• 00882916000516: 1.x
• 00882916000523: 2.1