AquaB LITE

GUDID 04251285200586

Additional membrane filtration unit for AquaB LITE water purification system. B2 LITE 500 for: AquaB LITE 1000 & B2 LITE 500 The AquaB LITE 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: 04251285200586
• NIH Device Record Key: 53112959-5be5-4930-b450-74328f56cdab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AquaB LITE
• Version Model Number: B2 LITE 500
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251285200586 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232953

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: 2024-08-02
• Device Publish Date: 2024-07-25

On-Brand Devices [AquaB LITE]

• 04251285200623: Additional membrane filtration unit for AquaB LITE water purification system. B2 LITE 2500 for:
• 04251285200616: Additional membrane filtration unit for AquaB LITE water purification system. B2 LITE 2000 for:
• 04251285200609: Additional membrane filtration unit for AquaB LITE water purification system. B2 LITE 1500 for:
• 04251285200593: Additional membrane filtration unit for AquaB LITE water purification system. B2 LITE 1000 for:
• 04251285200586: Additional membrane filtration unit for AquaB LITE water purification system. B2 LITE 500 for: A
• 04251285200579: The AquaB LITE is a modular reverse osmosis unit intended for use with hemodialysis systems to r
• 04251285200562: The AquaB LITE is a modular reverse osmosis unit intended for use with hemodialysis systems to r
• 04251285200555: The AquaB LITE is a modular reverse osmosis unit intended for use with hemodialysis systems to r
• 04251285200548: The AquaB LITE is a modular reverse osmosis unit intended for use with hemodialysis systems to r
• 04251285200531: The AquaB LITE is a modular reverse osmosis unit intended for use with hemodialysis systems to r
• 04251285200524: The AquaB LITE is a modular reverse osmosis unit intended for use with hemodialysis systems to r