Home GUDID 20884521809441 EsoFLIP
Primary DI 20884521809441
Brand EsoFLIP
Company Covidien LP
Model ES-320
Device description CATHETER ES-320 20MM ESO DILATION
Published 2021-03-15
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name PIE esophageal dilator with balloon and electrode sensors
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PIE Esophageal Dilator With Balloon And Electrode Sensors Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20884521809441 Package GS1 5 In Commercial Distribution 30884521809448 Package GS1 5 In Commercial Distribution 10884521809444 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20884521809441 20884521809441 30884521809448 30884521809448 10884521809444 10884521809444
GMDN Terms# Term, Definition table Term Definition Gastrointestinal/biliary dilation balloon catheter A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 0.5 KiloPascal 1.06 KiloPascal Handling Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Humidity 15 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Temperature 0 Degrees Celsius 25 Degrees Celsius Handling Environment Temperature 20 Degrees Celsius 40 Degrees Celsius Special Storage Condition, Specify 0 0 Fragile, Keep dry, This side up Storage Environment Atmospheric Pressure 0.7 KiloPascal 1.06 KiloPascal Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Humidity 15 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 0 Degrees Celsius 25 Degrees Celsius Storage Environment Temperature 20 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 058614483 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 false 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# 
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