Home GUDID B090LRN0590 LANDMARK
Primary DI B090LRN0590
Brand LANDMARK
Company ZIEN MEDICAL TECHNOLOGIES, INC.
Model LR-N-059
Catalog number LR-N-059
Device description The LANDMARK REBOA catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
Published 2024-01-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name DQY Catheter, Percutaneous MJN Catheter, Intravascular Occluding, Temporary
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQY Catheter, Percutaneous Cardiovascular 2 MJN Catheter, Intravascular Occluding, Temporary Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B090LRN0591 Package HIBCC 1 In Commercial Distribution B090LRN0592 Package HIBCC 5 In Commercial Distribution B090LRN0590 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Intravascular occluding balloon catheter, image-guided A non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Working Length 59 Centimeter Introducer Sheath Compatibilit 7 French
Regulatory Flags# DUNS number 017535668 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07613327623338 AXS Lift Stryker Corporation DQY 2025-03-04 07613327623376 AXS Lift Stryker Corporation DQY 2025-03-04 07613327417203 AXS Catalyst 7 Stryker Corporation DQY 2019-05-13 07613327417227 AXS Catalyst 7 Stryker Corporation DQY 2019-05-13 07613327313888 DAC 038 Stryker Corporation DQY 2016-09-21 07613327313901 DAC 057 Stryker Corporation DQY 2016-09-21 07613327313932 DAC 070 Stryker Corporation DQY 2016-09-21 07613327313949 DAC 057 Stryker Corporation DQY 2016-09-21 08033477054322 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054360 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054384 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054391 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054407 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054421 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477054438 Pacific™ Plus MEDTRONIC, INC. DQY 2016-06-26 08033477048772 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048802 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048833 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048864 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048888 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048925 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048956 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477048987 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049014 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049045 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049069 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049076 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049106 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049137 REEF HP MEDTRONIC, INC. DQY 2016-06-19 08033477049168 REEF HP MEDTRONIC, INC. DQY 2016-06-19