Home GUDID 10884450466626 TSX™
Primary DI 10884450466626
Brand TSX™
Company Merit Medical Systems, Inc.
Model 00884450466629
Catalog number M004TSXSHEATH300
Published 2021-05-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
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 10884450466626 Package GS1 5 In Commercial Distribution 00884450466629 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 10884450466626 10884450466626 00884450466629 00884450466629 884450466629 0884450466629
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 Device Size Text, specify 0
Regulatory Flags# DUNS number 184763290 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 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 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 H965355160 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355170 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355180 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355190 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965481000 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07