FFRangio FAU01000

GUDID 17290017855025

The FFRangio™ System, manufactured by CathWorks Ltd., is a non-invasive image-‎based software ‎device that provides physicians with a quantitative ana

CATHWORKS LTD

Diagnostic x-ray digital imaging system workstation

• Primary Device ID: 17290017855025
• NIH Device Record Key: 9492804a-c514-4f1c-9556-ac031daac30d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FFRangio
• Version Model Number: FAU01000
• Catalog Number: FAU01000
• Company DUNS: 600231478
• Company Name: CATHWORKS LTD
• 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: 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

Customer Support Contacts

• Phone: 949-330-6900
• Email: Jim.corbett@cath.works

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -7 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017855028 [Primary]
GS1	17290017855025 [Package]; Contains: 07290017855028; Package: crate [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182149

FDA Product Code

• QEK: Angiographic Coronary Vascular Physiologic Simulation Software

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: 2019-03-11
• Device Publish Date: 2019-02-12

On-Brand Devices [FFRangio]

• 17290017855025: The FFRangio™ System, manufactured by CathWorks Ltd., is a non-invasive image-‎based softwar
• 17290017855056: The FFRangio System is a non invasive image based software device