Primary Device ID | 00853341006008 |
NIH Device Record Key | 8f00a9e7-4fb5-431f-a163-2ebf1b6f6f5a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FFRct |
Version Model Number | v2.1 |
Company DUNS | 804411283 |
Company Name | HEARTFLOW, INC. |
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 | true |
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 | false |
OTC Over-The-Counter | false |
Phone | +16502410500 |
support@heartflow.com | |
Phone | +16502410500 |
support@heartflow.com | |
Phone | +16502410500 |
support@heartflow.com | |
Phone | +16502410500 |
support@heartflow.com | |
Phone | +16502410500 |
support@heartflow.com | |
Phone | +16502410500 |
support@heartflow.com | |
Phone | +16502410500 |
support@heartflow.com | |
Phone | +16502410500 |
support@heartflow.com | |
Phone | +16502410500 |
support@heartflow.com | |
Phone | +16502410500 |
support@heartflow.com | |
Phone | +16502410500 |
support@heartflow.com | |
Phone | +16502410500 |
support@heartflow.com | |
Phone | +16502410500 |
support@heartflow.com | |
Phone | +16502410500 |
support@heartflow.com | |
Phone | +16502410500 |
support@heartflow.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00853341006008 [Primary] |
PJA | Coronary Vascular Physiologic Simulation Software |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-08-01 |
00853341006022 | HeartFlow FFRct is coronary physiologic simulation software developed for the clinical quantitat |
00853341006015 | HeartFlow FFRct is an image analysis software developed for the clinical quantitative and qualit |
00853341006008 | HeartFlow FFRct is an image analysis software developed for the clinical quantitative and qualit |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() FFRCT 90808627 not registered Live/Pending |
Elucid Bioimaging Inc. 2021-07-02 |
![]() FFRCT 85334348 not registered Dead/Abandoned |
Heartflow, Inc. 2011-05-31 |
![]() FFRCT 85284255 4641484 Dead/Cancelled |
Heartflow, Inc. 2011-04-01 |