VIVONIC GmbH

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

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Device Description : The AquaA water purification system is a modular reverse osmosis unit intended f The 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 : The AquaA water purification system is a modular reverse osmosis unit intended f The 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 : The AquaA water purification system is a modular reverse osmosis unit intended f The 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 : The AquaA water purification system is a modular reverse osmosis unit intended f The 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 : The AquaA water purification system is a modular reverse osmosis unit intended f The 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 : The AquaA water purification system is a modular reverse osmosis unit intended f The 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 : The AquaA water purification system is a modular reverse osmosis unit intended f The 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 for AquaA water purification system.AquaA2 1 Additional membrane filtration unit for AquaA water purification system.AquaA2 1000 for:AquaA 2000 & AquaA2 1000The 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 for AquaA water purification system.AquaA2 2 Additional membrane filtration unit for AquaA water purification system.AquaA2 2000 for:AquaA 2000 & AquaA2 2000The 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 for AquaA water purification system.AquaA2 3 Additional membrane filtration unit for AquaA water purification system.AquaA2 3000 for:AquaA 3000 & AquaA2 3000The 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