Address:380 Lackawana Place,South Orange,NJ,07079,US
Device Description : The S100 Point of Use Filter is a disposable point-of-use micro-filter used to f The S100 Point of Use Filter is a disposable point-of-use micro-filter used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medicalprocedures and washing of surgeon’s hands.
Device Class :
Duns Number: 120664557
Premarket Exempt : No
Prescription Use : Yes
Device Description : S100 Handheld quick connect and packaging information
Device Class : 2
Duns Number: 120664557
Premarket Exempt : No
Prescription Use : Yes
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. It assists 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 inconjunction with other water treatment equipment (RO, DI, etc.).
Device Class : 2
Duns Number: 120664557
Premarket Exempt : No
Prescription Use : Yes
Device Description : The S100 Point of Use Filter is a disposable point of use micro-filter used to f The S100 Point of Use Filter is a disposable point of use micro-filter used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon’s hands.
Device Class :
Duns Number: 120664557
Premarket Exempt : No
Prescription Use : Yes
Device Description : Intended Use: The EndoPur Endotoxin 30” Filter is a hollow fiber ultrafilter th Intended Use: The EndoPur Endotoxin 30” Filter is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.Indications for Use: The EndoPur Endotoxin 30” 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 : 2
Duns Number: 120664557
Premarket Exempt : No
Prescription Use : Yes
Device Description : Intended Use: The EndoPur Endotoxin 40” Filter is a hollow fiber ultrafilter th Intended Use: The EndoPur Endotoxin 40” Filter is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.Indications for Use: The EndoPur Endotoxin 40” 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 : 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 : The MarCor ENX is intended to be used to filter water or bicarbonate concentrate The MarCor ENX is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists 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.).Use: The device is intended for long term continuous use. Once it completes its useful life, the filter should be replaced and discarded. Do not attempt to sterilize or reuse it.CONTRAINDICATIONSMedical: While the MarCor ENX produces ultrapure water, the water is not intended to be used in medical applications where USP sterile water is normally used.Chemical: The MarCor ENX retains biological contaminants. To obtain chemically pure water it is necessary to use the filter in conjunction with other devices such as DI beds or RO systems.
Device Class :
Duns Number: 120664557
Premarket Exempt : No
Prescription Use : Yes