AquaA

GUDID 04251285200326

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.

VIVONIC GmbH

Reverse-osmosis water purification system

• Primary Device ID: 04251285200326
• NIH Device Record Key: 86ee9eb2-b61e-4091-8d57-59e732f9ff77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AquaA
• Version Model Number: AquaA 2000
• Company DUNS: 341685795
• Company Name: VIVONIC GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 115 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 115 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 115 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 115 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 115 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 115 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 115 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 115 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 115 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 115 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 115 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 115 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251285200326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213507

FDA Product Code

• FIP: Subsystem, Water Purification

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-16
• Device Publish Date: 2022-08-08

On-Brand Devices [AquaA]

• 04251285200494: Additional ultrafiltration unit for AquaA water purification system. AquaUF 4000 for: AquaA 3000
• 04251285200487: Additional ultrafiltration unit for AquaA water purification system. AquaUF 2250 for: AquaA 1000
• 04251285200470: Additional heating unit for AquaA water purification system. AquaHT for: AquaA 900H & AquaHT Aqu
• 04251285200463: Additional membrane filtration unit (heat-disinfectable) for AquaA water purification system. Aq
• 04251285200456: Additional membrane filtration unit (heat-disinfectable) for AquaA water purification system. Aq
• 04251285200449: Additional membrane filtration unit (heat-disinfectable) for AquaA water purification system. Aq
• 04251285200432: Additional membrane filtration unit (heat-disinfectable) for AquaA water purification system. Aq
• 04251285200425: Additional membrane filtration unit for AquaA water purification system. AquaA2 4000 for: AquaA
• 04251285200418: Additional membrane filtration unit for AquaA water purification system. AquaA2 3000 for: AquaA
• 04251285200401: Additional membrane filtration unit for AquaA water purification system. AquaA2 2000 for: AquaA
• 04251285200395: Additional membrane filtration unit for AquaA water purification system. AquaA2 1000 for: AquaA
• 04251285200388: The AquaA water purification system is a modular reverse osmosis unit intended for use with hemo
• 04251285200371: The AquaA water purification system is a modular reverse osmosis unit intended for use with hemo
• 04251285200364: The AquaA water purification system is a modular reverse osmosis unit intended for use with hemo
• 04251285200357: The AquaA water purification system is a modular reverse osmosis unit intended for use with hemo
• 04251285200340: The AquaA water purification system is a modular reverse osmosis unit intended for use with hemo
• 04251285200333: The AquaA water purification system is a modular reverse osmosis unit intended for use with hemo
• 04251285200326: The AquaA water purification system is a modular reverse osmosis unit intended for use with hemo
• 04251285200319: The AquaA water purification system is a modular reverse osmosis unit intended for use with hemo