Home GUDID 08600035053013 SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System
Primary DI 08600035053013
Brand SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System
Company East End Medical I LLC
Model 3001
Catalog number 3001
Device description SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System.Small size.
Published 2022-04-05
Public version status Update
Distribution status Not 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 08600035053013 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08600035053013 08600035053013 8600035053013
GMDN Terms# Term, Definition table Term Definition Cardiac septostomy catheter, balloon A flexible tube with an inflatable balloon designed to create or enlarge the atrial septal defect found in the hearts of infants with congenital cardiac malformations. This allows interatrial blood mixing in infants with transposition of the great vessels. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 80 KiloPascal 109 KiloPascal Storage Environment Temperature -30 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 118148023 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08600035053020 SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System 3002 3002 2022-04-13 08600035053037 SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System 3003 3003 2022-04-13
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
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