Home GUDID H787103003015 DuraFlow
Primary DI H787103003015
Brand DuraFlow
Company ANGIODYNAMICS, INC.
Model 10300301
Device description 7F Double Access Hemodialysis Set
Published 2015-09-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name LFK CATHETER, FEMORAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LFK Catheter, Femoral Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status H787103003015 Package HIBCC 5 In Commercial Distribution H787103003010 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Double-lumen haemodialysis catheter, implantable A sterile, 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. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 7 French
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 27 Degrees Celsius
Regulatory Flags# DUNS number 079105071 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 true 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# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00884908029956 CAVH Catheter Medical Components, Inc. LFK 2016-04-29 00884908055894 CAVH Catheter Medical Components, Inc. LFK 2016-04-29 50884908029951 CAVH Catheter Medical Components, Inc. LFK 2016-04-29 50884908055899 CAVH Catheter Medical Components, Inc. LFK 2016-04-29 00884908029932 CAVH CATHETER Medical Components, Inc. LFK 2016-02-27 00884908029970 CAVH CATHETER Medical Components, Inc. LFK 2016-02-27 00884908053968 Femoral Catheter Medical Components, Inc. LFK 2016-02-27 50884908029937 CAVH CATHETER Medical Components, Inc. LFK 2016-02-27 50884908029975 CAVH CATHETER Medical Components, Inc. LFK 2016-02-27 50884908053963 Femoral Catheter Medical Components, Inc. LFK 2016-02-27 00884908026757 STRAIGHT FEMORAL Medical Components, Inc. LFK 2015-11-17 50884908026752 STRAIGHT FEMORAL Medical Components, Inc. LFK 2015-11-17 00884908053999 Femoral Catheter Medical Components, Inc. LFK 2015-11-11 50884908053994 Femoral Catheter Medical Components, Inc. LFK 2015-11-11 00884908054361 Femoral Catheter Medical Components, Inc. LFK 2015-10-24 00884908056181 CAVH Catheter Medical Components, Inc. LFK 2015-10-24 50884908054366 Femoral Catheter Medical Components, Inc. LFK 2015-10-24 50884908056186 CAVH Catheter Medical Components, Inc. LFK 2015-10-24 00884908026665 Femoral Catheter Medical Components, Inc. LFK 2015-10-23 00884908029390 CAVH Catheter Medical Components, Inc. LFK 2015-10-23 00884908029710 CAVH Catheter Medical Components, Inc. LFK 2015-10-23 50884908026660 Femoral Catheter Medical Components, Inc. LFK 2015-10-23 50884908029395 CAVH Catheter Medical Components, Inc. LFK 2015-10-23 50884908029715 CAVH Catheter Medical Components, Inc. LFK 2015-10-23 H787103003010 DuraFlow ANGIODYNAMICS, INC. LFK 2015-09-15
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