KDI

Product Code: KDI


Products Classified as KDI

1945Dialyzer, High Permeability With Or Without Sealed Dialysate SystemHigh Permeability Hemodialysis System.

Total Product Life Cycle (TPLC) Devices

1945Dialyzer, High Permeability With Or Without Sealed Dialysate SystemHigh Permeability Hemodialysis System.

FDA Consensus Standards

Dialyzer, High Permeability With Or Without Sealed Dialysate System [38695]21 CFR §876.5860 🔎
Dialyzer, High Permeability With Or Without Sealed Dialysate System [38694]21 CFR §876.5860 🔎
Dialyzer, High Permeability With Or Without Sealed Dialysate System [37765]21 CFR §876.5860 🔎
Dialyzer, High Permeability With Or Without Sealed Dialysate System [37766]21 CFR §876.5860 🔎

Pre-market Notifications for KDI

K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC
K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies Ltd
K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 SetBaxter Healthcare Corporation
K211370Tablo Hemodialysis SystemOutset Medical, Inc.
K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetQuanta Dialysis Technologies Ltd
K210575HDF Assist Mudule, HDF Infusion Set And Substitution FilterNephros
K201809AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber AccessoryBaxter Healthcare Corportation
K200741Tablo Hemodialysis SystemOutset Medical, Inc.
K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies Ltd.
K193542Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22Bellco Srl
K193482PrisMax System Version 3Baxter Healthcare Corporation
K193005DIMI RRT SystemDialco Medical Inc.
K192928Optiflux Enexa F500 DialyzerFresenius Medical Care Reanal Therapies Group LLC
K192756Aquadex FlexFlow System 2.0CHF Solutions, Inc.
K190910PrisMax System Version 2Baxter Healthcare Corp

Global Unique Device Identification Database

40383790008530Dialyzer, high permeability with or without sealed dialysate system
40383790008523Dialyzer, high permeability with or without sealed dialysate system
40383790008516Dialyzer, high permeability with or without sealed dialysate system
40383790008509Dialyzer, high permeability with or without sealed dialysate system
40383790008493Dialyzer, high permeability with or without sealed dialysate system
40383790008486Dialyzer, high permeability with or without sealed dialysate system
40383790007137Dialyzer, high permeability with or without sealed dialysate system
40383790007120Dialyzer, high permeability with or without sealed dialysate system
40383790007113Dialyzer, high permeability with or without sealed dialysate system
40383790007106Dialyzer, high permeability with or without sealed dialysate system
40383790007090Dialyzer, high permeability with or without sealed dialysate system
40383790007083Dialyzer, high permeability with or without sealed dialysate system
40383790007076Dialyzer, high permeability with or without sealed dialysate system
40383790007069Dialyzer, high permeability with or without sealed dialysate system
40383790004419Dialyzer, high permeability with or without sealed dialysate system

Maude Adverse Events

2008T HEMODIALYSIS SYSTEM W/BIBAGCONCORD MANUFACTURING2020-03-31
PRISMAFLEX HF1000BAXTER HEALTHCARE CORPORATION2020-03-31
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEMNXSTAGE MEDICAL, INC2020-03-31
POLYFLUX 14LBAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER2020-03-31
OPTIFLUX 200NRE DIALYZER FINISHED ASSY.OGDEN MANUFACTURING PLANT2020-03-30
POLYFLUX 17LBAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER2020-03-30
2008T HD SYS. CDX W/BIBAG BLUE STARCONCORD MANUFACTURING2020-03-30
NXSTAGE SYSTEM ONENXSTAGE MEDICAL, INC.2020-03-27
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.OGDEN MANUFACTURING PLANT2020-03-27
PRISMAFLEXBAXTER HEALTHCARE CORPORATION2020-03-27
PRISMAFLEX M150BAXTER HEALTHCARE - MEYZIEU2020-03-27
PRISMAFLEX M150BAXTER HEALTHCARE - MEYZIEU2020-03-27
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.OGDEN MANUFACTURING PLANT2020-03-27
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.OGDEN MANUFACTURING PLANT2020-03-27
PRISMAFLEX M150BAXTER HEALTHCARE - MEYZIEU2020-03-26
POLYFLUX 140HBAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER2020-03-26
ASAHI REXEED-S SERIES DIALYZERSASAHI KASEI MEDICAL CO., LTD.2020-03-26
ASAHI REXEED-S SERIES DIALYZERSASAHI KASEI MEDICAL CO., LTD.2020-03-26
ASAHI REXEED-S SERIES DIALYZERSASAHI KASEI MEDICAL CO., LTD.2020-03-26
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.OGDEN MANUFACTURING PLANT2020-03-25
POLYFLUX 140HBAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER2020-03-25
TABLO HEMODIALYSIS SYSTEMOUTSET MEDICAL, INC.2020-03-25
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.OGDEN MANUFACTURING PLANT2020-03-24
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.OGDEN MANUFACTURING PLANT2020-03-24
ASAHI REXEED-S SERIES DIALYZERSASAHI KASEI MEDICAL CO., LTD.2020-03-24
ASAHI REXEED-S SERIES DIALYZERSASAHI KASEI MEDICAL CO., LTD.2020-03-24
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.OGDEN MANUFACTURING PLANT2020-03-23
2008T HEMODIALYSIS SYS., WITH CDXCONCORD MANUFACTURING2020-03-23
PRISMAFLEX TPEBAXTER HEALTHCARE - MEYZIEU2020-03-23
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.OGDEN MANUFACTURING PLANT2020-03-23
REVACLEAR 400BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER2020-03-23
PRISMAFLEX HF1000BAXTER HEALTHCARE CORPORATION2020-03-23
POLYFLUX 140HBAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER2020-03-23
2008T HEMODIALYSIS SYS., WITH CDXCONCORD MANUFACTURING2020-03-20
2008T MACHINECONCORD MANUFACTURING2020-03-20
NXSTAGE SYSTEM ONENXSTAGE MEDICAL, INC.2020-03-20
NXSTAGE SYSTEM ONENXSTAGE MEDICAL, INC.2020-03-20
NXSTAGE SYSTEM ONENXSTAGE MEDICAL, INC.2020-03-20
NXSTAGE SYSTEM ONENXSTAGE MEDICAL, INC.2020-03-20
REVACLEAR 500BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER2020-03-20
PRISMAFLEX M150BAXTER HEALTHCARE - MEYZIEU2020-03-20
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEMNXSTAGE MEDICAL, INC.2020-03-20
PRISMAXBAXTER HEALTHCARE CORPORATION2020-03-19
PHOENIXGAMBRO RENAL PRODUCTS, INC.2020-03-19
REVACLEARGAMBRO RENAL PRODUCTS, INC.2020-03-19
OPTIFLUX 200NRE DIALYZER FINISHED ASSY.OGDEN MANUFACTURING PLANT2020-03-18
NXSTAGE SYSTEM ONENXSTAGE MEDICAL, INC.2020-03-18
PRISMAFLEXGAMBRO AB2020-03-18
2008K2 HEMODIALYSIS SYS OLC/DP, SPANISHCONCORD MANUFACTURING2020-03-17
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.OGDEN MANUFACTURING PLANT2020-03-17
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