Home GUDID 05414734203548 Fast-Cath™
Primary DI 05414734203548
Brand Fast-Cath™
Company ST. JUDE MEDICAL, INC.
Model 406949
Catalog number 406949
Device description Transseptal Guiding Introducer
Published 2015-04-14
Public version status Update
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 05414734203548 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05414734203548 05414734203548 5414734203548
GMDN Terms# Term, Definition table Term Definition Cardiac transseptal access set A collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It includes a vascular guide-catheter (which may be referred to as a steerable introducer) with a transseptal needle to create the puncture, and typically includes additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 8 French Length 81 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep dry, Keep away from sunlight, Protect from heat and radioactive sources Special Storage Condition, Specify 0 0 STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
Regulatory Flags# DUNS number 149818952 Device count 1 Lot or batch 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 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 H965355110 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355120 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355130 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07
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