Home GUDID 10884521809437 EsoFLIP
Primary DI 10884521809437
Brand EsoFLIP
Company Covidien LP
Model ES-310
Device description Endolumenal Functional Lumen Imaging Probe
Published 2021-03-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 20884521809434 Package GS1 5 In Commercial Distribution 30884521809431 Package GS1 5 In Commercial Distribution 10884521809437 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20884521809434 20884521809434 30884521809431 30884521809431 10884521809437 10884521809437
GMDN Terms# Term, Definition table Term Definition Gastrointestinal/biliary dilation balloon catheter, non-medicated 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, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 15 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity 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 50 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 0 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 058614483 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# 
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