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
OTC false
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 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 false 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 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 00849884007541 VYGON Vygon Corporation DYB 2026-05-22 00849884007558 VYGON Vygon Corporation DYB 2026-05-22 20886333227864 V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC. DYB 2026-03-20 20886333227871 V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC. DYB 2026-03-20 20886333227888 V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC. DYB 2026-03-20 20886333227895 V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC. DYB 2026-03-20 20886333227901 V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC. DYB 2026-03-20 20886333227918 V- Stick Vascular Access Set ARGON MEDICAL DEVICES, INC. DYB 2026-03-20 20886333227925 V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC. DYB 2026-03-20 20886333227932 V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC. DYB 2026-03-20 00813502010411 Impella RP Flex Introducer Kit Abiomed, Inc. DYB 2026-03-11 00813502011685 Abiomed Impella CP 14Fr Introducer Kit Abiomed, Inc. DYB 2026-03-11 00813502011692 Abiomed Impella CP 14Fr Introducer Kit Abiomed, Inc. DYB 2026-03-11 20801902225508 ARROW TELEFLEX INCORPORATED DYB 2026-03-11 20801902225546 ARROW TELEFLEX INCORPORATED DYB 2026-03-11 00840479401263 enableCV Introducer Sheath ENABLECV INC. DYB 2026-02-26 20884450113992 Prelude IDeal™ Merit Medical Systems, Inc. DYB 2026-02-25 20884450115804 Prelude IDeal™ Merit Medical Systems, Inc. DYB 2026-02-25 00884450489642 Prelude SNAP™ Merit Medical Systems, Inc. DYB 2026-02-21 30884908188456 MICRO-STICK SET Medical Components, Inc. DYB 2026-02-19 30884908188463 MICRO-STICK SET Medical Components, Inc. DYB 2026-02-19 50884908188474 MICRO-STICK SET Medical Components, Inc. DYB 2026-02-19 50884908188481 MICRO-STICK SET Medical Components, Inc. DYB 2026-02-19 20801902225362 ARROW TELEFLEX INCORPORATED DYB 2026-02-17 20884450119475 Prelude EASE™ Merit Medical Systems, Inc. DYB 2026-02-14 50382903829120 Insyte Autoguard BECTON, DICKINSON AND COMPANY DYB 2026-02-13 30382903829249 Insyte Autoguard BECTON, DICKINSON AND COMPANY DYB 2026-02-13 50382903829472 Insyte Autoguard BECTON, DICKINSON AND COMPANY DYB 2026-02-13 50382903829540 Insyte Autoguard BECTON, DICKINSON AND COMPANY DYB 2026-02-13 20801902225133 ARROW TELEFLEX INCORPORATED DYB 2026-02-13
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