LIFClass II
Dialyzer Reprocessing System
Gastroenterology, Urology · 21 CFR 876.5820
MDR events137All time
Recalls1All time
Registered firms11Currently listed
510(k) clearances57All time
Recent MDR events
137 adverse event reports on file
- RENALIN PR TEST SYSTEM PACKETApr 18, 2017MalfunctionMinntech/medivatorMW5069232
- MINNCARE 500ML WEEKLYAug 8, 2014MalfunctionGambroMW5037753
- RENALIN 100Feb 8, 2008InjuryMinntech Corp.2150060-2008-00002
- *Aug 3, 2007Injury*1221361-2007-00056
- *Aug 3, 2007Injury*1221361-2007-00057
- *Aug 3, 2007Death*1221361-2007-00058
- RENALINOct 31, 2005InjuryMinntech2150060-2005-00007
- RENALINJan 7, 2005OtherMinntech Corp.2150060-2005-00001
- RENALINDec 30, 2004OtherMinntech Corp.2150060-2004-00037
- FRESENIUS HEMODIALYZERMar 15, 2004InjuryFresenius Medical Care518709
Event type breakdown
Injury66
Other42
Malfunction25
Death3
Unspecified1
Recalls
1 recall events for this product code
Registered firms
11 firms currently registered for this product code
510(k) clearances
57 clearances for this product code
- Novaflux TechnologiesNov 3, 2010
K091360 · CLEARFLUX DIALYZER REPROCESSING SYSTEM
- Alcavis International, Inc.Feb 3, 2005
K043126 · ASSIST HEADER CLEANER
- Hach CompanyNov 15, 2004
K040660 · STERICHEK GLUTARALDEHYDE REAGENT STRIPS
- Minntech Corp.Apr 27, 2004
K033505 · RENACLEAN SH DIALYZER CLEANING SYSTEM
- Hdc Maquinolas, LLCSep 26, 2003
K024076 · MAKY 21.1 DIALYZER REPROCESSING SYSTEM
- Alcavis International IncorporatedJul 15, 2002
K013713 · ARM AUTOMATIC REPROCESSING MACHINE
- Amuchina Intl., Inc.Jan 10, 2000
K992016 · AMUKIN D
- Minntech Corp.Aug 30, 1999
K991851 · RENACLEAR DIALYZER CLEANING SYSTEM