Home GUDID H787103018015 DuraFlow
Primary DI H787103018015
Brand DuraFlow
Company ANGIODYNAMICS, INC.
Model 10301801
Device description HemoDialysis Catheter Repair Kit
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 NFK Kit, repair, catheter, hemodialysis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NFK Kit, Repair, Catheter, Hemodialysis Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status H787103018015 Package HIBCC 5 In Commercial Distribution H787103018010 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.
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 20801902197379 ARROW TELEFLEX INCORPORATED NFK 2022-12-08 10801902197372 ARROW TELEFLEX INCORPORATED NFK 2022-12-08 20801902197355 ARROW TELEFLEX INCORPORATED NFK 2022-12-02 30801902197352 ARROW TELEFLEX INCORPORATED NFK 2022-12-02 20801902197409 ARROW TELEFLEX INCORPORATED NFK 2022-12-01 20801902197461 ARROW TELEFLEX INCORPORATED NFK 2022-12-01 20801902197485 ARROW TELEFLEX INCORPORATED NFK 2022-12-01 10801902197402 ARROW TELEFLEX INCORPORATED NFK 2022-12-01 30801902197468 ARROW TELEFLEX INCORPORATED NFK 2022-12-01 10801902197488 ARROW TELEFLEX INCORPORATED NFK 2022-12-01 20801902195337 ARROW TELEFLEX INCORPORATED NFK 2022-11-15 20801902196723 ARROW TELEFLEX INCORPORATED NFK 2022-11-15 30801902195334 ARROW TELEFLEX INCORPORATED NFK 2022-11-15 30801902196720 ARROW TELEFLEX INCORPORATED NFK 2022-11-15 20801902195238 ARROW TELEFLEX INCORPORATED NFK 2022-11-11 30801902195235 ARROW TELEFLEX INCORPORATED NFK 2022-11-11 20801902197423 ARROW TELEFLEX INCORPORATED NFK 2022-11-09 10801902197426 ARROW TELEFLEX INCORPORATED NFK 2022-11-09 00884908158205 CATHETER REPAIR KIT Medical Components, Inc. NFK 2020-11-26 30884908158206 CATHETER REPAIR KIT Medical Components, Inc. NFK 2020-11-26 00884908146042 N/A Medical Components, Inc. NFK 2019-09-05 30884908146043 N/A Medical Components, Inc. NFK 2019-09-05 00801741045080 Catheter Repair Kit Bard Access Systems, Inc. NFK 2017-05-29 10801741045087 Catheter Repair Kit Bard Access Systems, Inc. NFK 2017-05-29 00801741045103 Catheter Repair Kit Bard Access Systems, Inc. NFK 2015-12-04 00801741045110 RetrO Catheter Repair Kit Bard Access Systems, Inc. NFK 2015-12-04 20801741045107 Catheter Repair Kit Bard Access Systems, Inc. NFK 2015-12-04 20801741045114 RetrO Catheter Repair Kit Bard Access Systems, Inc. NFK 2015-12-04 00884908039658 CATHETER REPAIR KIT Medical Components, Inc. NFK 2015-10-24 00884908039856 REPAIR KIT Medical Components, Inc. NFK 2015-10-23
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