Terumo Aortic Balloon 28-W1-50-08-120G

GUDID 00853892004447

Aortic Balloon Catheter, 120cm

QXMEDICAL

Intravascular occluding balloon catheter, image-guided
Primary Device ID00853892004447
NIH Device Record Keye6d2b476-eb51-4e05-aab7-3b9da8b650c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameTerumo Aortic Balloon
Version Model Number120cm
Catalog Number28-W1-50-08-120G
Company DUNS022672652
Company NameQXMEDICAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com
Phone651-842-2050
Emailadmin@qxmedical.com

Device Dimensions

Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter
Introducer Sheath Compatibilit10 French
Catheter Length120 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100853892004447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-13
Device Publish Date2021-09-03

Devices Manufactured by QXMEDICAL

00853892004447 - Terumo Aortic Balloon2021-09-13Aortic Balloon Catheter, 120cm
00853892004447 - Terumo Aortic Balloon2021-09-13 Aortic Balloon Catheter, 120cm
00853892004140 - Camaro Support Catheter2020-07-23 Support Catheter, 180cm effective length, compatible with 0.035" Guidewires
00853892004157 - Camaro Support Catheter2020-07-23 Support Catheter, 150 cm working length, compatible with .035" guidewires
00853892004164 - Camaro Support Catheter2020-07-23 Support Catheter, 135 cm working length, compatible with 0.035" guidewires
00853892004171 - Camaro Support Catheter2020-07-23 Support Catheter, 90 cm working length, compatible with .035" guidewires
00853892004188 - Camaro Support Catheter2020-07-23 Support Catheter, 65 cm working length, compatible with 0.035" guidewires
00853892004195 - Camaro Support Catheter2020-07-23 Support Catheter, 180 cm working length, compatible with 0.018" guidewires
00853892004201 - Camaro Support Catheter2020-07-23 Support Catheter, 150 cm working length, compatible with 0.018" guidewires
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.