AquaC

GUDID 04251285200234

The AquaC UNO H Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodia

VIVONIC GmbH

Reverse-osmosis water purification system

• Primary Device ID: 04251285200234
• NIH Device Record Key: 2cb8582b-fa3c-463a-aa84-3b9f588bb6b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AquaC
• Version Model Number: UNO H
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251285200234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143617

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

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