AquaBplus & AquaBplus B2 & AquaBplus HF

GUDID 04251285200197

The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substanc

VIVONIC GmbH

Reverse-osmosis water purification system

• Primary Device ID: 04251285200197
• NIH Device Record Key: af411305-d13b-4242-b3ec-f0a8c4a8d542
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AquaBplus & AquaBplus B2 & AquaBplus HF
• Version Model Number: 1000
• 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 Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251285200197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133829

FDA Product Code

• FIP: Subsystem, Water Purification

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [AquaBplus & AquaBplus B2 & AquaBplus HF]

• 04251285200227: The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodia
• 04251285200210: The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodia
• 04251285200203: The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodia
• 04251285200197: The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodia
• 04251285200180: The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodia