Address:380 Lackawana Place,South Orange,NJ,07079,US
Device Description : The Nephros SSUmini is intended to be used to filter water or bicarbonate concen The Nephros SSUmini is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. Itassists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
Device Class : 2
Duns Number: 120664557
Premarket Exempt : No
Prescription Use : Yes
Device Description : The HydraGuard 10" UltraFilter is intended to be used to filter EPA quality drin The HydraGuard 10" UltraFilter is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for washing and drinking, the filter aids in infection control. The filter produces water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s handsContraindications:Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water.
Device Class :
Duns Number: 120664557
Premarket Exempt : No
Prescription Use : No
Device Description : The HydraGuard 10” UltraFilter - Fin is intended to be used to filter EPA qualit The HydraGuard 10” UltraFilter - Fin is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for washing and drinking, the filter aids in infection control. The filter produces water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s handsContraindications:Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water.
Device Class : 2
Duns Number: 120664557
Premarket Exempt : No
Prescription Use : No
Device Description : Description: The HydraGuard 10” UltraFilter - Flush is a hollow fiber ultrafilte Description: The HydraGuard 10” UltraFilter - Flush is a hollow fiber ultrafilter that retains bacteria, viruses, and endotoxin from water.Indications for Use: The HydraGuard 10” UltraFilter - Flush is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filter aids in infection control. The filter produces water that is suitable for patient wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands. The filter is not intended to provide wa
Device Class : 2
Duns Number: 120664557
Premarket Exempt : No
Prescription Use : No
Device Description : Intended Use: The EndoPur Endotoxin 10” Filter Flat is a hollow fiber ultrafilte Intended Use: The EndoPur Endotoxin 10” Filter Flat is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.Indications for Use: The EndoPur Endotoxin 10” Filter Flat is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
Device Class : 2
Duns Number: 120664557
Premarket Exempt : No
Prescription Use : Yes
Device Description : Intended Use: The EndoPur Endotoxin 10” Filter Fin is a hollow fiber ultrafilter Intended Use: The EndoPur Endotoxin 10” Filter Fin is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.Indications for Use: The EndoPur Endotoxin 10” Filter Fin is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
Device Class : 2
Duns Number: 120664557
Premarket Exempt : No
Prescription Use : Yes
Device Description : Intended Use: The EndoPur Endotoxin 20” Filter is a hollow fiber ultrafilter th Intended Use: The EndoPur Endotoxin 20” Filter is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.Indications for Use: The EndoPur Endotoxin 20” Filter is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
Device Class :
Duns Number: 120664557
Premarket Exempt : No
Prescription Use : Yes
Device Description : Intended Use: The EndoPur Endotoxin 10” Filter Flat is a hollow fiber ultrafilte Intended Use: The EndoPur Endotoxin 10” Filter Flat is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.Indications for Use: The EndoPur Endotoxin 10” Filter Flat is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
Device Class :
Duns Number: 120664557
Premarket Exempt : No
Prescription Use : Yes
Device Description : The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bact The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
Device Class :
Duns Number: 120664557
Premarket Exempt : No
Prescription Use : Yes
Device Description : The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bact The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
Device Class :
Duns Number: 120664557
Premarket Exempt : No
Prescription Use : Yes