Home GUDID 17290017855025 FFRangio
Primary DI 17290017855025
Brand FFRangio
Company CATHWORKS LTD
Model FAU01000
Catalog number FAU01000
Device description The FFRangio™ System, manufactured by CathWorks Ltd., is a non-invasive image-based software device that provides physicians with a quantitative ana
Published 2019-02-12
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name QEK Angiographic Coronary Vascular Physiologic Simulation Software
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QEK Angiographic Coronary Vascular Physiologic Simulation Software Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 17290017855025 Package GS1 1 In Commercial Distribution 07290017855028 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 17290017855025 17290017855025 07290017855028 07290017855028 7290017855028
GMDN Terms# Term, Definition table Term Definition Diagnostic x-ray digital imaging system workstation A freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be integrated as part of a radiology picture archiving and communication system (PACS). It consists of dedicated hardware (e.g., computer processing unit, monitor) with integrated software typically to assist image analysis (e.g., viewing, manipulation, interpretation); it does not include controls for direct operation of the imaging system.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 20 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature -7 Degrees Fahrenheit 140 Degrees Fahrenheit
Regulatory Flags# DUNS number 600231478 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# 
cath.works