FKP

Product Code: FKP


Products Classified as FKP

1907System, Dialysate Delivery, Single PatientHemodialysis System And Accessories.

Total Product Life Cycle (TPLC) Devices

1907System, Dialysate Delivery, Single PatientHemodialysis System And Accessories.

FDA Consensus Standards

System, Dialysate Delivery, Single Patient [36807]21 CFR §876.5820 🔎
System, Dialysate Delivery, Single Patient [36809]21 CFR §876.5820 🔎
System, Dialysate Delivery, Single Patient [36808]21 CFR §876.5820 🔎
System, Dialysate Delivery, Single Patient [38695]21 CFR §876.5820 🔎
System, Dialysate Delivery, Single Patient [38694]21 CFR §876.5820 🔎

Pre-market Notifications for FKP

K181991NxStage Connected Health SystemNxStage Medical, Inc
K131739NXSTAGE CONNECTED HEALTH SYSTEMNXSTAGE MEDICAL, INC.
K130460NXSTAGE DOSING CALCULATORNXSTAGE MEDICAL, INC.
K040074ONEVIEW INTERFACENXSTAGE MEDICAL, INC.
K021060FRESENIUS ICARE MONITORING SYSTEMFRESENIUS MEDICAL CARE NORTH AMERICA
K003615STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPSENVIRONMENTAL TEST SYSTEMS, INC.
K992255CKHEMO, MODEL CKHEMO VERSION 1.0CSAM, INC.
K964264HIGH RANGE PEROXIDE TEST STRIPINTEGRATED BIOMEDICAL TECHNOLOGY, INC.
K955423PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAMFRESENIUS USA, INC.
K953854WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDEINTEGRATED BIOMEDICAL TECHNOLOGY, INC.
K930181BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATEFRESENIUS USA, INC.
K921456FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEMFRESENIUS USA, INC.
K910215DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTCD MEDICAL, INC.
K905793COBE CENTRY 2 BICART OPTION KITCOBE LABORATORIES, INC.
K905388COBE CENTRYSYSTEM 3 BICART OPTION KITCOBE LABORATORIES, INC.

Global Unique Device Identification Database

00842289101890System, Dialysate Delivery, Single Patient
00842289101883System, Dialysate Delivery, Single Patient
M535NX1272System, Dialysate Delivery, Single Patient
M535NX1225NX1380System, Dialysate Delivery, Single Patient
M535NX1225NX1379System, Dialysate Delivery, Single Patient
G212HP20401System, Dialysate Delivery, Single Patient

Maude Adverse Events

NXSTAGE DIALYSIS CYCLERNXSTAGE MEDICAL, INC.2019-08-05
NXSTAGE DIALYSIS CYCLERNXSTAGE MEDICAL, INC.2019-08-05
NXSTAGE DIALYSIS CYCLERNXSTAGE MEDICAL, INC.2019-08-05
NXSTAGE DIALYSIS CYCLERNXSTAGE MEDICAL, INC.2019-08-05
DIALYSIS BAGNXSTAGE MEDICAL, INC.2018-08-29
MEDICATION BAGNXSTAGE MEDICAL, INC.2018-04-25
DRUG BAGNXSTAGE MEDICAL INC.2018-04-09
DRUG BAGNXSTAGE MEDICAL INC.2018-04-09
NXSTAGE / DIALYSIS BAGNXSTAGE2018-03-28
ONEVIEW DIALYSIS MACHINENXSTAGE MEDICAL2018-01-02
PHOENIXGAMBRO2015-06-15
FRESENIUS 2008TFRESENIUS MEDICAL CARE2014-04-02
NXSTAGENXSTAGE MEDICAL2013-10-24
FRESENIUS 2008 TFRESENIUS MEDICAL CARE2013-09-06
WATERCHECK 2INTEGRATED BIOMEDICAL TECHNOLOGY, INC.2011-10-21
WATERCHECK 2INTEGRATED BIOMEDICAL TECHNOLOGY, INC.2011-10-21
SYSTEM 1000BAXTER HEALTHCARE - LARGO2011-05-27
1500 HEMODIALYSIS MACHINEBAXTER HEALTHCARE - LARGO2011-05-26
FRESENIUS DIALYSIS DELIVERY SYSTEMFRESENIUS MEDICAL CARE-NORTH AMERICA2011-01-28
CENTRYSYSTEM 3GAMBRO RENAL PRODUCTS2010-12-29
GAMBROGAMBRO AMERICAS HEADQUARTERS2010-11-29
FRESENIUS DIALYSIS DELIVERY SYSTEMFRESENIUS MEDICAL CARE NORTH AMERICA2010-08-20
U0707 TINA SINGLE PUMP NIBPLCDBAXTER HEALTHCARE - LARGO2010-04-21
FRESENIUS 2008KFRESENIUS USA, INC2010-04-07
U1104 1550 SINGLE PATIENTSYSTEMBAXTER HEALTHCARE - LARGO2010-03-15
OBS 10/02 SPS550 220V MSMCOMPATIBLE W/VARIABLE SODIUMBAXTER HEALTHCARE - TAMPA2010-02-15
OBS 10/02 SPS550 220V MSMCOMPATIBLE W/VARIABLE SODIUMBAXTER HEALTHCARE - TAMPA2010-02-15
B BRAUN HEMODIALYSIS UNITB BRAUN2010-01-07
TINA SINGL PUMP NIBP LCDBAXTER HEALTHCARE - MIAMI LAKES2009-11-30
U0707 S1000 TINA HD MACHINEREFURBBAXTER HEALTHCARE - LARGO2009-11-13
U0707 S1000 TINA HD MACHINEREFURBBAXTER HEALTHCARE - LARGO2009-11-13
TINA SYSTEM 1000 MACHINEUSED - EXCELLENT CONDITIONBAXTER HEALTHCARE - LARGO2009-10-23
U0707 TINA DOUBLE PUMP CE LCDBAXTER HEALTHCARE - LARGO2009-09-25
U1105 S1000 TINA HD WITH NIBPBAXTER HEALTHCARE - LARGO2009-07-02
U0707 S1000 TINA HD MACHINEREFURBBAXTER HEALTHCARE2009-05-27
FRESENIUS DIALYSIS MACHINEFRESENIUS USA2009-05-18
FRESENIUS DIALYSIS MACHINEFRESENIUS USA2009-05-18
FRESENIUS DIALYSIS MACHINEFRESENIUS USA2009-05-18
FRESENIUS DIALYSIS MACHINEFRESENIUS USA2009-05-18
FRESENIUS DIALYSIS MACHINEFRESENIUS USA2009-05-18
FRESENIUS DIALYSIS MACHINEFRESENIUS USA2009-05-18
FRESENIUS DIALYSIS MACHINEFRESENIUS USA2009-05-18
FRESENIUS DIALYSIS MACHINEFRESENIUS USA2009-05-18
FRESENIUS DIALYSIS MACHINEFRESENIUS USA2009-05-18
U1104 1550 SINGLE PATIENT SYSTEMBAXTER HEALTHCARE - LARGO2009-05-04
U070 TINA SINGLE PUMP LCDBAXTER HEALTHCARE - LARGO2009-04-16
FRESENIUS DIALYSIS DELIVERY SYSTEMFRESENIUS MEDICAL CARE-NORTH AMERICA2009-04-10
BAXTER ARENA DIALYSIS MACHINEBAXTER HEALTHCARE2009-03-19
TINA SYSTEM 1000 MACHINE USED - EXCELLENT CONDITIONBAXTER HEALTHCARE - LARGO2009-03-17
FRESENIUS USAFRESENIUS USA2009-02-20
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