FFRangio FAU0400

GUDID 17290017855056

The FFRangio System is a non invasive image based software device

CATHWORKS LTD

Diagnostic x-ray digital imaging system workstation

• Primary Device ID: 17290017855056
• NIH Device Record Key: 24341169-aeec-4c08-800d-57341aa96f48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FFRangio
• Version Model Number: FAU0400
• Catalog Number: FAU0400
• 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: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works
• Phone: 949-330-6900
• Email: ayelet.peer@cath.works

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017855059 [Primary]
GS1	17290017855056 [Package]; Contains: 07290017855059; Package: crate [1 Units]; In Commercial Distribution

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: 2020-01-03
• Device Publish Date: 2019-12-26

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