Home GUDID 10884521157897 Palindrome
Primary DI 10884521157897
Brand Palindrome
Company Mozarc Medical US LLC
Model 8888128461P
Device description Precision H Chronic Catheter Sport Pack,Symmetrical Tip, Heparin Coating, Pre-Curved Shaft and Tal VenaTrac Stylet,14.5 Fr/Ch (4.8 mm) x 28 cm
Published 2014-09-22
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 NYU Catheter, hemodialysis, implanted, coated
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NYU Catheter, Hemodialysis, Implanted, Coated Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20884521157894 Package GS1 5 In Commercial Distribution 10884521157897 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20884521157894 20884521157894 10884521157897 10884521157897
GMDN Terms# Term, Definition table Term Definition Double-lumen haemodialysis catheter, implantable An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 14.5 French Length 28 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 59 Degrees Fahrenheit 86 Degrees Fahrenheit Special Storage Condition, Specify 0 0 ;AVOID DIRECT SUNLIGHT Special Storage Condition, Specify 0 0 Keep away from sunlight. Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 118997146 Device count 1 Kit true Combination product true Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# 
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