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 |
Phone | 949-330-6900 |
Jim.corbett@cath.works |
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 Issuing Agency | Device ID |
---|---|
GS1 | 07290017855028 [Primary] |
GS1 | 17290017855025 [Package] Contains: 07290017855028 Package: crate [1 Units] In Commercial Distribution |
QEK | Angiographic Coronary Vascular Physiologic Simulation Software |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-03-11 |
Device Publish Date | 2019-02-12 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() FFRANGIO 87106889 not registered Live/Pending |
CathWorks Ltd. 2016-07-18 |