Home GUDID B090LRN0591 LANDMARK
Primary DI B090LRN0591
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
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name MJN Catheter, Intravascular Occluding, Temporary
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class 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 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810060550816 Bridge Plus occlusion balloon Philips Image Guided Therapy Corporation MJN 2025-10-09 00850001105118 Prytime Medical Devices, Inc. Prytime Medical Devices, Inc. MJN 2025-06-20 00842429117545 SCEPTER Microvention, Inc. MJN 2025-04-30 00842429117552 SCEPTER Microvention, Inc. MJN 2025-04-30 00842429117569 SCEPTER Microvention, Inc. MJN 2025-04-30 00842429117583 SCEPTER Microvention, Inc. MJN 2025-04-30 00842429106884 Balloon Catheter Microvention, Inc. MJN 2025-04-22 00842429106891 Balloon Catheter Microvention, Inc. MJN 2025-04-22 00842429106907 Balloon Catheter Microvention, Inc. MJN 2025-04-22 00842429106945 Balloon Catheter Microvention, Inc. MJN 2025-04-22 10628678061054 COBRA-OS® Front Line Medical Technologies Inc. MJN 2024-03-22 10628678061061 Syringe, 10 mL Front Line Medical Technologies Inc. MJN 2024-03-22 B090LRN0590 LANDMARK ZIEN MEDICAL TECHNOLOGIES, INC. MJN 2024-01-23 10628678061009 COBRA-OS™ Front Line Medical Technologies Inc. MJN 2023-08-25 10628678061016 COBRA-OS™ Front Line Medical Technologies Inc. MJN 2023-08-25 10628678061023 Syringe, 10 mL Front Line Medical Technologies Inc. MJN 2023-08-25 20763000293424 Cadence ™ Precision Injector Thread 1 mL Syringe Micro Therapeutics, Inc. MJN 2022-12-23 00850001105057 Prytime Medical Devices Inc. Prytime Medical Devices, Inc. MJN 2022-12-15 00850001105064 Prytime Medical Devices, Inc. Prytime Medical Devices, Inc. MJN 2022-12-15 00842429103388 Balloon Catheter Microvention, Inc. MJN 2022-06-14 00842429103395 Balloon Catheter Microvention, Inc. MJN 2022-06-14 00842429103401 Balloon Catheter Microvention, Inc. MJN 2022-06-14 00842429103418 Balloon Catheter Microvention, Inc. MJN 2022-06-14 00853359008414 Sniper Embolx, Inc. MJN 2022-05-18 16286780610016 COBRA-OS™ Front Line Medical Technologies Inc. MJN 2022-02-09 16286780610023 Syringe, 10 mL Front Line Medical Technologies Inc. MJN 2022-02-09 16286780610009 COBRA-OS™ Front Line Medical Technologies Inc. MJN 2022-01-28 00853892004447 Terumo Aortic Balloon QXMEDICAL MJN 2021-09-03 00857545008011 Walrus Q'APEL MEDICAL LLC MJN 2021-06-29 00857545008028 Walrus Q'APEL MEDICAL LLC MJN 2021-06-29