Home GUDID 08600035053020 SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System
Primary DI 08600035053020
Brand SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System
Company East End Medical I LLC
Model 3002
Catalog number 3002
Device description SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System, Medium.
Published 2022-04-13
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 08600035053020 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08600035053020 08600035053020 8600035053020
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 08600035053037 SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System 3003 3003 2022-04-13 08600035053013 SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System 3001 3001 2022-04-05
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