FII

Product Code: FII


Products Classified as FII

1858System, Dialysate Delivery, SealedHigh Permeability Hemodialysis System.

Total Product Life Cycle (TPLC) Devices

1858System, Dialysate Delivery, SealedHigh Permeability Hemodialysis System.

FDA Consensus Standards

System, Dialysate Delivery, Sealed [36807]21 CFR §876.5860 🔎
System, Dialysate Delivery, Sealed [36809]21 CFR §876.5860 🔎
System, Dialysate Delivery, Sealed [36808]21 CFR §876.5860 🔎

Pre-market Notifications for FII

K030470NXSTAGE SYSTEM ONENXSTAGE MEDICAL, INC.
K881270GAMBRO MULTIPURPOSE SYSTEM MPS-10GAMBRO, INC.
K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309TRAVENOL LABORATORIES, S.A.
K862716HEMOFILTRATION SYSTEM 10GAMBRO, INC.
K822386COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPAHOSPAL MEDICAL CORP.

Maude Adverse Events

2008 MACHINE2014-04-03
REVEACLEAR DIALYIZERGAMBRO2014-01-10
GAMBRO REVACLEAR DIALYZER K6GAMBRO2013-12-13
2008K HEMODIALYSIS MACHINCEFRESENIUS MEDICAL CARE NORTH AMERICA2013-11-21
*DIALYZERFRESENIUS USA, INC2013-05-15
5 LITER ACCESSORY DRAIN BAGGAMBRO-RENAL PRODUCTS2012-12-10
FRESENIUS DIALYSIS DELIVERY SYSTEMFRESENIUS MEDICAL CARE NORTH AMERICA2012-04-26
GAMBROGAMBRO2012-01-11
GAMBROGAMBRO2012-01-11
CRRT MACHINEGAMBRO RENAL PRODUCTS, INC.2010-12-20
GAMBROGAMBRO AMERICAS HEADQUARTERS2010-11-29
GAMBROGAMBRO AMERICAS HEADQUARTERS2010-11-29
GAMBROGAMBRO AMERICAS HEADQUARTERS2010-11-29
GAMBROGAMBRO AMERICAS HEADQUARTERS2010-11-24
GAMBROGAMBRO AMERICAS HEADQUARTERS2010-11-24
GAMBROGAMBRO AMERICAS HEADQUARTERS2010-11-24
GAMBROGAMBRO AMERICAS HEADQUARTERS2010-11-24
GAMBROGAMBRO AMERICAS HEADQUARTERS2010-11-24
GAMBROGAMBRO AMERICAS HEADQUARTERS2010-11-24
GAMBRO PHOENIX DIALYSIS MACHINEGAMBRO AMERICAS HEADQUARTERS2010-11-24
PRISMAGAMBRO2010-05-28
CRRTGAMBRO2010-05-22
FRESENIUS DIALYSIS MACHINEFRESENIUS2010-04-16
AQUARIUSEDWARDS LIFESCIENCES2010-02-12
9 LITER ACCESSORY DRAIN BAG (1 SP-418)GAMBRO RENAL PRODUCTS2010-02-07
9 LITER ACCESSORY DRAIN BAG (1 SP-418)GAMBRO RENAL PRODUCTS2010-02-07
PRISMASATE 500 CC DIALYSIS SOLUTIONGAMBRO2009-12-28
*HEMODIALYSIS, CONTINUOUS RENAL REPLACEMENT THERAPYGAMBRO RENAL PRODUCTS, INC.2009-12-13
*HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT THERAPYGAMBRO RENAL PRODUCTS, INC.2009-12-13
*HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT THERAPYGAMBRO RENAL PRODUCTS, INC.2009-12-13
*EFFLUENT BAG, DRAINAGEGAMBRO RENAL PRODUCTS, INC.2009-12-13
9 LITER UF DRAIN BAGGAMBRO RENAL PRODUCTS, INC.2009-12-13
*HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT THERAPYGAMBRO RENAL PRODUCTS, INC2009-12-13
*EFFLUENT BAG, DRAINAGEGAMBRO RENAL PRODUCTS, INC.2009-12-13
*HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT THERAPYGAMBRO RENAL PRODUCTS, INC2009-12-13
*HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT THERAPYGAMBRO RENAL PRODUCTS, INC.2009-12-13
*HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT THERAPYGAMBRO RENAL PRODUCTS, INC.2009-12-13
*HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT THERAPYGAMBRO RENAL PRODUCTS, INC.2009-12-13
9 LITER DRAINAGE BAGGAMBRO RENAL PRODUCTS, INC.2009-12-12
*HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT THERAPYGAMBRO RENAL PRODUCTS, INC2009-12-12
*HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT THERAPYGAMBRO RENAL PRODUCTS, INC.2009-12-12
*HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT THERAPYGAMBRO RENAL PRODUCTS, INC.2009-12-12
*HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT THERAPYGAMBRO RENAL PRODUCTS, INC.2009-12-12
*HEMODIALYSIS MACHINEFRESENIUS MEDICAL CARE NORTH AMERICA2009-12-05
PRISMASATE DIALYSIS SOLUTION FOR CONTINUOUS RENAL REPLACEMENT THERAPY 5000ML BAGGAMBRO2009-12-02
*BAG, HEMODIALYSIS, CONTINUOUS RENAL REPLACEMENT THERAPYGAMBRO RENAL PRODUCTS, INC.2009-11-15
*BAG, HEMODIALYSIS, CONTINUOUS RENAL REPLACEMENT THERAPYGAMBRO RENAL PRODUCTS, INC2009-11-15
*DIALYSIS MACHINEFRESENIUS MEDICAL CARE NORTH AMERICA2009-10-30
FRESENIUS 2008KFRESENIUS USA2009-10-30
CENTRYSYSTEM 3 PLUSGAMBRO2009-10-30
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