Home GUDID M535SLE3011M30985 Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie
Primary DI M535SLE3011M30985
Brand Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie
Company MEDISYSTEMS CORPORATION
Model SLE-3011M3098
Published 2015-09-01
Public version status Update
Distribution status Not 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 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M535SLE3011M30985 Package HIBCC 9 Not in Commercial Distribution M535SLE3011M30980 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Haemodialysis/haemofiltration system component set A collection of sterile devices, which includes a dialyser, intended to be integrated within a system for haemodialysis and haemofiltration to treat acute or chronic renal failure by removing toxins and/or replacing electrolytes in blood; it may also be used in the treatment of fluid overload (hypervolemia). In addition to the dialyser the set includes an array of tubing and connectors, and is intended to be connected to the system pump/monitor; it is intended to be used in the home and healthcare settings. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep dry Storage Environment Humidity 0 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 061310132 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 true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M535M820062 ViraGuard Viral Blocking Patient Transducer Protector M8-2006 2015-09-01 M535M89001E0 Reverso Clamp Flow Reversing Interconnector for Hemodialysis Blood Tubing Set M8-9001E 2015-09-01 M535SLE3000M30950 Streamline Express Dialyzer with Pre-attached Tubing Set For Fresenius 2008 Seri SLE-3000M3095 2015-09-01 M535SLE3010M30960 Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie SLE-3010M3096 2015-09-01 M535SLE3011M30980 Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie SLE-3011M3098 2015-09-01 M535SLE3000M30955 Streamline Express Dialyzer with Pre-attached Tubing Set For Fresenius 2008 Seri SLE-3000M3095 2015-09-01 M535SLE3010M30965 Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie SLE-3010M3096 2015-09-01 00842289100879 Medisystems Hemodialysis Fistula Needle Set with MasterGuard S9-4005MG 2016-09-16 00842289100886 Medisystems Hemodialysis Fistula Needle Set with MasterGuard S9-4006MG 2016-09-16 00842289100893 Medisystems Hemodialysis Fistula Needle Set with MasterGuard S9-4007MG 2016-09-16 00842289100909 Medisystems Hemodialysis Fistula Needle Set with MasterGuard S9-4015MG 2016-09-16 00842289100916 Medisystems Hemodialysis Fistula Needle Set with MasterGuard S9-4016MG 2016-09-16 00842289100923 Medisystems Hemodialysis Fistula Needle Set with MasterGuard S9-4017MG 2016-09-16 00842289100428 Medisystems Hemodialysis Fistula Needle Set with MasterGuard D9-7015MG 2016-09-16 00842289100435 Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard D9-2015MG 2016-09-16 00842289100442 Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard D9-2015MG 2016-09-16 00842289100459 Medisystems Hemodialysis Fistula Needle Set with MasterGuard D9-7016MG 2016-09-16 00842289100466 Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard D9-2016MG 2016-09-16 00842289100473 Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard D9-2016MG 2016-09-16 00842289100480 Medisystems Hemodialysis Fistula Needle Set with MasterGuard D9-4005MG 2016-09-16
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