Home GUDID G44VIZ125D0 Multiflex
Primary DI G44VIZ125D0
Brand Multiflex
Company Vizaramed, Inc.
Model VIZ125D
Device description A steerable, sterile, single-use, percutaneous introducer sheath with dilator used to facilitate placement of various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Published 2024-12-05
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 DYB Introducer, Catheter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DYB Introducer, Catheter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status G44VIZ125D0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Vascular guide-catheter, single-use A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Inner Diameter 4.28 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -18 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 117711573 Device count 1 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 G440VIZ1750 Multiflex VIZ175 VIZ175 2026-04-09 G44VIZ1550 Multiflex VIZ155 VIZ155 2023-09-18 G44VIZ1250 Multiflex VIZ125 VIZ125 2023-09-18
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10884450114008 Prelude IDeal™ Merit Medical Systems, Inc. DYB 2026-06-09 10884450119799 Prelude EASE™ Merit Medical Systems, Inc. DYB 2026-06-09 10884450114855 Prelude IDeal™ Merit Medical Systems, Inc. DYB 2026-06-08 00850084947001 Genie MAX CULTIV8 1, LLC DYB 2026-05-29 G440VIZ1750 Multiflex Vizaramed, Inc. DYB 2026-04-09 08498840011300 VYGON Vygon Corporation DYB 2019-04-08 08498840011317 VYGON Vygon Corporation DYB 2019-04-08 08498840011751 VYGON Vygon Corporation DYB 2019-04-08 08498840011768 VYGON Vygon Corporation DYB 2019-04-08 08498840011775 VYGON Vygon Corporation DYB 2019-04-08 08498840011782 VYGON Vygon Corporation DYB 2019-04-08 08498840011799 VYGON Vygon Corporation DYB 2019-04-08 08498840011805 VYGON Vygon Corporation DYB 2019-04-08 08498840011812 VYGON Vygon Corporation DYB 2019-04-08 08498840012215 VYGON Vygon Corporation DYB 2019-04-08 H965481030 ENVI NAVILYST MEDICAL, INC. DYB 2019-01-03 07613327459210 AXS VECTA 71 Stryker Corporation DYB 2018-10-26 07613327459227 AXS VECTA 71 Stryker Corporation DYB 2018-10-26 07613327459234 AXS VECTA 71 Stryker Corporation DYB 2018-10-26 00813502010664 Introducer Kit for Impella® Oscor Inc. DYB 2017-11-30 00813502010237 Introducer Kit for Impella® Oscor Inc. DYB 2017-11-18 00813502010244 Introducer Kit for Impella® Oscor Inc. DYB 2017-11-18 00813502010558 Introducer Kit for Impella® Oscor Inc. DYB 2017-11-18 H965481080 Navylist NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355010 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355020 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355030 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355060 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355080 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355090 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07
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