AQUAbase® LA1101376

GUDID 04046955725175

AQUAbase nX 750HT (60Hz/208-220V)

B.Braun Avitum AG

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

• Primary Device ID: 04046955725175
• NIH Device Record Key: 17c1f6c1-9f7c-44c9-90e8-555b92ba5b2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQUAbase®
• Version Model Number: LA1101376
• Catalog Number: LA1101376
• Company DUNS: 343689704
• Company Name: B.Braun Avitum AG
• 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: false
• 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

Customer Support Contacts

• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com
• Phone: +1(800)848-2066
• Email: rtd.us@bbraun.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046955725175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223479

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: 2023-10-17
• Device Publish Date: 2023-10-09

On-Brand Devices [AQUAbase®]

• 04046955725175: AQUAbase nX 750HT (60Hz/208-220V)
• 04046955725168: AQUAbase® nX HT 500 Reverse Osmosis System
• 04046955725151: AQUAbase® nX HT 250 Reverse Osmosis System