System, Dialysate Delivery, Central Multiple Patient
Gastroenterology, Urology · 21 CFR 876.5820
Recent MDR events
19 adverse event reports on file
- CENTRISOL ACID CONCENTRATEOct 18, 2024MalfunctionMedivators Inc.2150060-2024-00055
- CENTRISOL ACID CONCENTRATESep 25, 2024MalfunctionMedivators Inc.2150060-2024-00046
- CENTRISOL ACID CONCENTRATESep 25, 2024MalfunctionMedivators Inc.2150060-2024-00048
- CENTRISOL ACID CONCENTRATEAug 29, 2024MalfunctionMedivators Inc.MW5159069
- CENTRISOL ACID CONCENTRATE, CA2.5 K2.0, 1 GALLONAug 2, 2024MalfunctionMedivators IncMW5157961
- CENTRISOL ACID CONCENTRATE, CA2.5 K3.0, 1 GALLONAug 2, 2024MalfunctionMedivators IncMW5157962
- ACID DIALYSATE BATHDec 20, 2023MalfunctionMedivators Inc2150060-2023-00054
- ACID DIALYSATE BATHNov 1, 2023OtherMedivators, Inc.MW5147611
- SYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENTAug 12, 2023DeathMedivatorsMW5136414
- CENTRISOL HEMODIALYSIS ACID CONCENTRATEApr 23, 2021MalfunctionMedivators2150060-2021-00006
Event type breakdown
Recalls
2 recall events for this product code
- B. Braun Medical, Inc.TerminatedApr 26, 2013
Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367.
There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane permeability (ultrafiltration coefficient).
Z-1183-2013 · View FDA record ↗ - Medivators, Inc.TerminatedUnknown
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machin
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Z-1859-2021 · View FDA record ↗
Registered firms
6 firms currently registered for this product code
510(k) clearances
61 clearances for this product code
- B. Braun Medizintechnologie GmbHJun 9, 2006
K052764 · DIACAP ULTRA DIALYSIS FLUID FILTER
- National Medical Care, Medical Products Div., Inc.Jul 24, 1989
K893612 · TWO TANK DISSOLUTION MODULE
- National Medical Care, Medical Products Div., Inc.Apr 27, 1988
K874084 · MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM
- Kawasumi Laboratories Co., Ltd.Oct 9, 1987
K873421 · KAWASUMI A.V. FISTULA SET
- D.R.G. Scientific IndustriesJul 8, 1987
K870889 · ACID FUCHSIN SOLUTIONS
- Renal Systems, Inc.Jun 9, 1987
K861730 · ACTRIL FOR KIDNEY MACHINE DISINFECTANT
- National Medical Care, Medical Products Div., Inc.Jan 13, 1987
K864635 · FOUR TANK DISSOLUTION MODULE
- Cd Medical, Inc.Sep 9, 1986
K862304 · DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM