VIVONIC GmbH

Address:Kurfuerst-Eppstein-Ring 4,Sailauf Bavaria,DE

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Device Description : Additional membrane filtration unit for AquaA water purification system.AquaA2 4 Additional membrane filtration unit for AquaA water purification system.AquaA2 4000 for:AquaA 4000 & AquaA2 4000The AquaA water purification system is a modular 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. This device is intended to be a component in 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 post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

Device Class : 2

Duns Number: 341685795

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : Additional membrane filtration unit (heat-disinfectable) for AquaA water purific Additional membrane filtration unit (heat-disinfectable) for AquaA water purification system.AquaA2 900H for:AquaA 1800H & AquaA2 900HAquaA 1800H & AquaA2 900H & AquaHTThe AquaA water purification system is a modular 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. This device is intended to be a component in 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 post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

Device Class : 2

Duns Number: 341685795

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : Additional membrane filtration unit (heat-disinfectable) for AquaA water purific Additional membrane filtration unit (heat-disinfectable) for AquaA water purification system.AquaA2 1800H for:AquaA 1800H & AquaA2 1800HAquaA 1800H & AquaA2 1800H & AquaHTThe AquaA water purification system is a modular 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. This device is intended to be a component in 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 post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

Device Class : 2

Duns Number: 341685795

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : Additional membrane filtration unit (heat-disinfectable) for AquaA water purific Additional membrane filtration unit (heat-disinfectable) for AquaA water purification system.AquaA2 2700H for:AquaA 2700H & AquaA2 2700HAquaA 2700H & AquaA2 2700H & AquaHTThe AquaA water purification system is a modular 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. This device is intended to be a component in 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 post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

Device Class : 2

Duns Number: 341685795

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : Additional membrane filtration unit (heat-disinfectable) for AquaA water purific Additional membrane filtration unit (heat-disinfectable) for AquaA water purification system.AquaA2 3600H for:AquaA 3600H & AquaA2 3600HAquaA 3600H & AquaA2 3600H & AquaHTThe AquaA water purification system is a modular 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. This device is intended to be a component in 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 post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

Device Class : 2

Duns Number: 341685795

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : Additional heating unit for AquaA water purification system.AquaHT for:AquaA 900 Additional heating unit for AquaA water purification system.AquaHT for:AquaA 900H & AquaHTAquaA 1800H & AquaA2 900H & AquaHTAquaA 1800H & AquaHTAquaA 1800H & AquaA2 1800H & AquaHTAquaA 2700H & AquaHTAquaA 2700H & AquaA2 2700H & AquaHTAquaA 3600H & AquaHTAquaA 3600H & AquaA2 3600H & AquaHTThe AquaA water purification system is a modular 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. This device is intended to be a component in 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 post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

Device Class : 2

Duns Number: 341685795

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : Additional ultrafiltration unit for AquaA water purification system.AquaUF 2250 Additional ultrafiltration unit for AquaA water purification system.AquaUF 2250 for:AquaA 1000 & AquaUF 2250AquaA 2000 & AquaA2 1000 & AquaUF 2250AquaA 2000 & AquaUF 2250AquaA 2000 & AquaA2 2000 & AquaUF 2250AquaA 900H & AquaUF 2250AquaA 1800H & AquaA2 900H & AquaUF 2250AquaA 1800H & AquaA2 900H & AquaHT & AquaUF 2250AquaA 1800H & AquaUF 2250AquaA 1800H & AquaA2 1800H & AquaUF 2250AquaA 1800H & AquaA2 1800H & AquaHT & AquaUF 2250The AquaA water purification system is a modular 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. This device is intended to be a component in 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 post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

Device Class : 2

Duns Number: 341685795

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : Additional ultrafiltration unit for AquaA water purification system.AquaUF 4000 Additional ultrafiltration unit for AquaA water purification system.AquaUF 4000 for:AquaA 3000 & AquaUF 4000AquaA 3000 & AquaA2 3000 & AquaUF 4000AquaA 4000 & AquaUF 4000AquaA 4000 & AquaA2 4000 & AquaUF 4000AquaA 2700H & AquaUF 4000AquaA 2700H & AquaA2 2700H & AquaUF 4000AquaA 2700H & AquaA2 2700H & AquaHT & AquaUF 4000AquaA 3600H & AquaUF 4000AquaA 3600H & AquaA2 3600H & AquaUF 4000AquaA 3600H & AquaA2 3600H & AquaHT & AquaUF 4000The AquaA water purification system is a modular 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. This device is intended to be a component in 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 post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

Device Class : 2

Duns Number: 341685795

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

Device Description : The Visual LED Indicator is used to remotely monitor the operating status of a c The Visual LED Indicator is used to remotely monitor the operating status of a connected device (e.g. the reverse osmosis water treatment system).The status of a connected device is signaled:– Visually by three indicator lights (green, yellow, and red)– Acoustically by a sound generatorAn acoustic status signal can be muted temporarily at the touch of a button.The signaling device can currently be operated with the following reverse osmosis systems from Fresenius:– AquaA– AquaBplus

Device Class : 2

Duns Number: 341685795

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

Device Description : The AquaDETECTOR leakage monitoring system provides full leakage monitoring of a The AquaDETECTOR leakage monitoring system provides full leakage monitoring of a dialysis center in the monitored areas. It can be used to switch off dialysis water supply systems, dialysis concentrate preparation systems, dialysis concentrate supply systems, booster pump assemblies, and pre-filtration devices that are connected to the central control unit.This device can be used with the AquaA and AquaBplus water purification systems.

Device Class : 2

Duns Number: 341685795

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1