Home GUDID 00850041053035 Malibu Aspiration Catheter System
Primary DI 00850041053035
Brand Malibu Aspiration Catheter System
Company Innova Vascular, Inc.
Model MALIBU12A-001
Device description One (1) Malibu Aspiration Catheter System: Malibu Aspiration Catheter, Dilator, and Syringe
Published 2024-01-05
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 KRA Catheter, Continuous Flush QEW Peripheral Mechanical Thrombectomy With Aspiration
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRA Catheter, Continuous Flush Cardiovascular 2 QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850041053035 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850041053035 00850041053035 850041053035 0850041053035
GMDN Terms# Term, Definition table Term Definition Thrombectomy suction catheterization kit A collection of devices intended to be used during a percutaneous transluminal thrombectomy suction procedure (in conjunction with a syringe or dedicated suction pump system) and which includes a thrombectomy suction catheter and additional devices intended to support catheter introduction and function (e.g., dilator, clot buster, haemostasis valve, aspiration tubing). This is a single-use device.
Regulatory Flags# DUNS number 118406653 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850041053004 Malibu Aspiration Catheter System MALIBU24A-001 2024-01-05 00850041053011 Malibu Aspiration Catheter System MALIBU20A-001 2024-01-05 00850041053028 Malibu Aspiration Catheter System MALIBU16A-001 2024-01-05 00850041053042 Malibu Aspiration Catheter System MALIBU12-001 2024-01-05 00850041053059 Malibu Aspiration Catheter System MALIBU16-001 2024-01-05 00850041053066 Malibu Aspiration Catheter System MALIBU20-001 2024-01-05 00850041053073 Malibu Aspiration Catheter System MALIBU24-001 2024-01-05 00850041053080 Laguna Clot Retriever System LAGUNA10-001 2024-01-05 00850041053097 Laguna Clot Retriever System LAGUNA14-001 2024-01-05 00850041053103 Laguna Clot Retriever System LAGUNA10A-001 2024-01-05 00850041053110 Laguna Clot Retriever System LAGUNA14A-001 2024-01-05
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07640132622690 M-CATH Flexy Acrostak (Schweiz) AG KRA 2021-11-01 07640132622706 M-CATH Flexy Acrostak (Schweiz) AG KRA 2021-11-01 08714729968740 ZelanteDVT™ ClotHunter™ BOSTON SCIENTIFIC CORPORATION QEW 2020-11-04 07640132622157 M-CATH Microcatheter Acrostak (Schweiz) AG KRA 2018-05-15 10351688507990 Medex ICU MEDICAL, INC. KRA 2016-12-30 10351688508669 Medex ICU MEDICAL, INC. KRA 2016-12-30 10351688505620 Medex ICU MEDICAL, INC. KRA 2016-12-29 10351688508768 Medex ICU MEDICAL, INC. KRA 2016-10-19 10351688508775 Medex ICU MEDICAL, INC. KRA 2016-10-19 10351688508782 Medex ICU MEDICAL, INC. KRA 2016-10-19 10351688508805 Medex ICU MEDICAL, INC. KRA 2016-10-19 10351688506856 Medex ICU MEDICAL, INC. KRA 2016-10-12 10351688506863 Medex ICU MEDICAL, INC. KRA 2016-10-12 10351688508898 Medex ICU MEDICAL, INC. KRA 2016-10-11 10351688509932 Medex ICU MEDICAL, INC. KRA 2016-10-11 08714729235118 Renegade™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729235125 Renegade™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280583 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280590 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280606 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280613 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280620 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280637 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280644 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280651 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280668 Renegade™ HI-FLO™ BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280736 Renegade™ HI-FLO™ Kit BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280743 Renegade™ HI-FLO™ Kit BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280750 Renegade™ HI-FLO™ Kit BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24 08714729280767 Renegade™ HI-FLO™ Kit BOSTON SCIENTIFIC CORPORATION KRA 2016-09-24