Home GUDID 20884521809410 EndoFLIP
Primary DI 20884521809410
Brand EndoFLIP
Company Covidien LP
Model EF-322N
Device description ENDO CATHETER EF-322N 16CM NASAL TIP
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 FFX SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FFX System, Gastrointestinal Motility (Electrical) Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20884521809410 Package GS1 5 In Commercial Distribution 30884521809417 Package GS1 5 In Commercial Distribution 10884521809413 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20884521809410 20884521809410 30884521809417 30884521809417 10884521809413 10884521809413
GMDN Terms# Term, Definition table Term Definition Manometric gastrointestinal motility analysis system An assembly of devices which includes a main computerized unit designed to evaluate peristaltic motility in the gastrointestinal tract by measuring pressure using an intraluminal sensor catheter/probe at several points; it may also measure pH, respiration, and swallowing with appropriate sensors. In addition to the central computer with software it may includethe appropriate perfusion and/or nonperfusion catheters. It is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), noncardiac chest pain, and/or assess connective tissue and neuromuscular disease.
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 20 Degrees Celsius 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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