Visual LED Indicator

GUDID 04251285200500

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 generator An 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

VIVONIC GmbH

Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system

• Primary Device ID: 04251285200500
• NIH Device Record Key: 66057577-b9b9-44b0-881a-fae3e7276b7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visual LED Indicator
• Version Model Number: -
• 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 0 Percent (%) Relative Humidity and 80 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 0 Percent (%) Relative Humidity and 80 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 0 Percent (%) Relative Humidity and 80 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 0 Percent (%) Relative Humidity and 80 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 0 Percent (%) Relative Humidity and 80 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 0 Percent (%) Relative Humidity and 80 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 0 Percent (%) Relative Humidity and 80 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 0 Percent (%) Relative Humidity and 80 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 0 Percent (%) Relative Humidity and 80 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 0 Percent (%) Relative Humidity and 80 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 0 Percent (%) Relative Humidity and 80 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 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 115 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251285200500 [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

Devices Manufactured by VIVONIC GmbH

• 04251285200319 - AquaA: 2022-08-16 The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organ
• 04251285200326 - AquaA: 2022-08-16 The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organ
• 04251285200333 - AquaA: 2022-08-16 The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organ
• 04251285200340 - AquaA: 2022-08-16 The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organ
• 04251285200357 - AquaA: 2022-08-16 The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organ
• 04251285200364 - AquaA: 2022-08-16 The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organ
• 04251285200371 - AquaA: 2022-08-16 The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organ
• 04251285200388 - AquaA: 2022-08-16 The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organ