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510(k) Data Aggregation
K Number
K143617Device Name
AquaC UNO H
Manufacturer
VIVONIC GMBH
Date Cleared
2015-10-19
(304 days)
Product Code
FIP
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
VIVONIC GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AquaC UNO H Portable Water Purification System is a reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies.
The AquaC UNO H can be connected to hemodialysis equipment used in hospitals, clinics and in home environments. This device is intended to be a complete water purification system, and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by posttreatment devices as well, to meet current AAMI/ANSI and FDA recognized U.S. standards.
Device Description
The AquaC UNO H Water Purification System is a microcontrolled, fully automatic reverse osmosis system with heat disinfection function which uses pretreated soft water for the production of highly deionized water, also called permeate.
The intended use of the reverse osmosis device is to remove organic and inorganic ions and microbiological contaminants from the feed water to fulfill the requirements of ISO 13959 'water for haemodialysis and related therapies'.
The feed water must be of drinking water standard, filtered, free of iron, softened and free of chlorine. Potentially critical limits must be monitored by regular checks.
Bacterial growth in the system must be prevented by continuous operation of the system with a minimum of idle times and by preventive measures such as chemical or heat disinfection.
The device consists of a water inlet section where the inflowing volume of water is volumetrically measured. The water is stored in a break tank and is used by the pump to generate high pressure. The pump generates the high pressure and transports the water to the membrane.
The permeate flows from the membrane through the conductivity cell to the permeate outlet into the ring main. The ring main can be connected directly to a dialysis machine.
The concentrate is discarded via the drain valve to the drain.
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K Number
K133829Device Name
AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
Manufacturer
VIVONIC GMBH
Date Cleared
2014-04-22
(126 days)
Product Code
FIP
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
VIVONIC GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
Device Description
The AquaBplus is a microcontrolled, fully automatic reverse osmosis which uses pretreated soft water for the production of highly deionized water for use by hemodialysis devices and for the preparation of dialysis concentrates.
The intended use of the reverse osmosis device is to remove organic and inorganic ions and microbiological contaminants from the feed water to fulfill the requirements of ISO 13959 'water for haemodialysis and related therapies'.
The feed water must be of drinking water standard, filtered, free of iron, softened and free of chlorine. Potentially critical limits must be monitored by regular checks.
Bacterial growth in the system must be prevented by continuous operation of the system with a minimum of idle times and by preventive measures such as chemical disinfection. If there is a need, the quality of the permeate could be raised by using the AquaBplus B2 as a second reverse osmosis (2nd membrane filtration step). The AquaBplus B2 is a module that will be installed after the AquaBplus (=main reverse osmosis).
To allow an automatic heat disinfection of the permeate ring main, the module AquaBplus HF could be installed afterwards the AquaBplus/AquaB2. The heat disinfection could take place in dialysis free times.
The produced dialysis permeate will be transferred to the permeate ring main by pressure, where it will be distributed to the different withdrawal units of the dialysis machines. Alternatively permeate could be transferred into a permeate storage tank system. A permeate distribution system (pump, filter, tubing) follows normally to a permeate storage system. In most cases, the feed line into the permeate storage tank is realized as a ring main. Because the most installation type is the ring main and to ease the following description, the components following the AquaBplus system is simply called "ring main".
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