RO, MIILENIUM HX, 4118, 115~, 60HZ

GUDID 00817492022508

Evoqua Water Technologies Corp.

Reverse-osmosis water purification system

• Primary Device ID: 00817492022508
• NIH Device Record Key: 08e2e141-bc6a-4029-8508-ae355ff15641
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RO, MIILENIUM HX, 4118, 115~, 60HZ
• Version Model Number: W3T577749
• Company DUNS: 079427087
• Company Name: Evoqua Water Technologies Corp.
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817492022508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192398

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: 2024-05-27
• Device Publish Date: 2024-05-17

Devices Manufactured by Evoqua Water Technologies Corp.

• 00817492023710 - RO, EON, 115~, 50/60HZ: 2024-06-06
• B486W5TDICAR0025FFQR0 - SDI EXCHANGE TANK 0.25 CU/FT CARBON BC1240: 2024-05-30
• B486W5TDICAR0045FFQR0 - SDI EXCHANGE TANK 0.45 CU/FT CARBON BC1240: 2024-05-30
• B486W5TDICAR0054FFQR0 - SDI EXCHANGE TANK 0.54 CU/FT CARBON BC1240: 2024-05-30
• B486W5TDICAR0079FFQR0 - SDI EXCHANGE TANK 0.79 CU/FT CARBON BC1240: 2024-05-30
• B486W5TDICAR0360FSQR0 - SDI EXCHANGE TANK 3.6 CU/FT CARBON BC1240: 2024-05-30
• B486W5TDICAR0500FSQR0 - SDI EXCHANGE TANK 5.0 CU/FT CARBON BC1240: 2024-05-30
• B486W5TDICAR0600FSQR0 - SDI EXCHANGE TANK 6.0 CU/FT CARBON BC1240: 2024-05-30