CoroFlow Upgrade kit

GUDID 07350111070663

Software upgrade for Coroventis CoroFlow System

COROVENTIS Research AB

Cardiac catheterization laboratory computer

• Primary Device ID: 07350111070663
• NIH Device Record Key: 6a570c4f-cf26-4116-b8c2-bb3ce1837ec3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoroFlow Upgrade kit
• Version Model Number: 12000-20
• Company DUNS: 352954840
• Company Name: COROVENTIS Research AB
• 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: true
• 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	07350111070663 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201881

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

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: 2022-03-09
• Device Publish Date: 2022-03-01

Devices Manufactured by COROVENTIS Research AB

• 07350111070663 - CoroFlow Upgrade kit: 2022-03-09Software upgrade for Coroventis CoroFlow System
• 07350111070663 - CoroFlow Upgrade kit: 2022-03-09 Software upgrade for Coroventis CoroFlow System
• 07350111070014 - CoroFlow: 2020-12-28