Home GUDID 05391530810043 EsoFLIP
Primary DI 05391530810043
Brand EsoFLIP
Company Covidien LP
Model ES-330
Device description EsoFLIP Dilation Catheter for use with EndoFLIP System
Published 2016-08-02
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 PID Esophageal Dilator Balloon With Or Without Electrode Sensors PIE Esophageal Dilator With Balloon And Electrode Sensors
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PID Esophageal Dilator Balloon With Or Without Electrode Sensors Gastroenterology, Urology 2 PIE Esophageal Dilator With Balloon And Electrode Sensors Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05391530810098 Package GS1 5 In Commercial Distribution 05391530810043 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05391530810098 05391530810098 5391530810098 05391530810043 05391530810043 5391530810043
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.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 30 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition 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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