FFRangio

Primary DI
07290017855059
Brand
FFRangio
Company
CATHWORKS LTD
Model
FAU04000
Catalog number
FAU04000
Device description
The FFRangio System is a non invasive image based software device
Published
2019-12-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QEKAngiographic Coronary Vascular Physiologic Simulation Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEKAngiographic Coronary Vascular Physiologic Simulation SoftwareCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017855056PackageGS11In Commercial Distribution
07290017855059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001785505617290017855056
07290017855059072900178550597290017855059

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging system workstationA 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.

Contacts#

Phone, Email table
PhoneEmail
+972 545649707reut.magen@cath.works
949-330-6900ayelet.peer@cath.works

Regulatory Flags#

DUNS number
600231478
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017855028FFRangioFAU01000FAU010002019-02-12
17290017855056FFRangioFAU0400FAU04002019-12-26
17290017855025FFRangioFAU01000FAU010002019-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17290017855056FFRangioCATHWORKS LTDQEK2019-12-26
07290017855028FFRangioCATHWORKS LTDQEK2019-02-12
17290017855025FFRangioCATHWORKS LTDQEK2019-02-12