Home GUDID 00827002465602 Echotip Insight
Primary DI 00827002465602
Brand Echotip Insight
Company COOK IRELAND LTD
Model G46560
Catalog number ECHO-PPG
Device description Echotip Insight Portosystemic Pressure Gradient Measurement System
Published 2019-12-12
Public version status Update
Distribution status 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 QIJ Endoscopic transhepatic venous access needle
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QIJ Endoscopic Transhepatic Venous Access Needle Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00827002465602 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00827002465602 00827002465602 827002465602 0827002465602
GMDN Terms# Term, Definition table Term Definition Endoscopic portal pressure measurement system An assembly of devices intended to measure hepatic portal pressure gradient by direct measurements of pressure within the hepatic vein and portal vein using a needle inserted via the stomach or duodenum under ultrasound guidance during endoscopy. It consists of a fine needle, a mechanical manometer with connection tubing, and a syringe. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in dark, dry, cool place. Avoid extended exposure to light.
Regulatory Flags# DUNS number 988559035 Device count 1 Kit true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# 
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