AmeriWater Water Purification System for Hemodialysis

GUDID 00817927020338

AmeriWater Water Purification System for Hemodialysis including reverse osmosis with pre-treatment and post-treatment intended to produce water that meets all current AAMI and Federal (U.S.) standards for water used in hemodialysis.

AMERIWATER, LLC

Reverse-osmosis water purification system

• Primary Device ID: 00817927020338
• NIH Device Record Key: 0f397fdc-4ac8-41ca-b433-5c4496bb481d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AmeriWater Water Purification System for Hemodialysis
• Version Model Number: Complete System
• Company DUNS: 836758342
• Company Name: AMERIWATER, LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817927020338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991519

FDA Product Code

• FIP: Subsystem, Water Purification

Sterilization

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

[00817927020338]

High-level Disinfectant;Peracetic Acid;Moist Heat or Steam Sterilization

[00817927020338]

High-level Disinfectant;Peracetic Acid;Moist Heat or Steam Sterilization

[00817927020338]

High-level Disinfectant;Peracetic Acid;Moist Heat or Steam Sterilization

[00817927020338]

High-level Disinfectant;Peracetic Acid;Moist Heat or Steam Sterilization

[00817927020338]

High-level Disinfectant;Peracetic Acid;Moist Heat or Steam Sterilization

[00817927020338]

High-level Disinfectant;Peracetic Acid;Moist Heat or Steam Sterilization

[00817927020338]

High-level Disinfectant;Peracetic Acid;Moist Heat or Steam Sterilization

[00817927020338]

High-level Disinfectant;Peracetic Acid;Moist Heat or Steam Sterilization

[00817927020338]

High-level Disinfectant;Peracetic Acid;Moist Heat or Steam Sterilization

[00817927020338]

High-level Disinfectant;Peracetic Acid;Moist Heat or Steam Sterilization

[00817927020338]

High-level Disinfectant;Peracetic Acid;Moist Heat or Steam Sterilization

[00817927020338]

High-level Disinfectant;Peracetic Acid;Moist Heat or Steam Sterilization

[00817927020338]

High-level Disinfectant;Peracetic Acid;Moist Heat or Steam Sterilization

[00817927020338]

High-level Disinfectant;Peracetic Acid;Moist Heat or Steam Sterilization

[00817927020338]

High-level Disinfectant;Peracetic Acid;Moist Heat or Steam Sterilization

[00817927020338]

High-level Disinfectant;Peracetic Acid;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-15
• Device Publish Date: 2023-06-07

Devices Manufactured by AMERIWATER, LLC

• 00817927020321 - AmeriWater MediQA 00MSP3HF-230: 2023-06-15 MediQA, Single Pass, 3 Membrane, up to 23,040 GPD, 208/230V, 3 Ph
• 00817927020338 - AmeriWater Water Purification System for Hemodialysis: 2023-06-15AmeriWater Water Purification System for Hemodialysis including reverse osmosis with pre-treatment and post-treatment intended to produce water that meets all current AAMI and Federal (U.S.) standards for water used in hemodialysis.
• 00817927020338 - AmeriWater Water Purification System for Hemodialysis: 2023-06-15 AmeriWater Water Purification System for Hemodialysis including reverse osmosis with pre-treatment and post-treatment intended t
• 00817927020000 - AmeriWater MROS: 2018-07-06 MROS, Single Patient Portable RO, 730 GPD, 115V
• 00817927020017 - AmeriWater MRO1: 2018-07-06 MRO1 (1 to 2 Stations Portable RO), 1,400 GPD, 115V
• 00817927020024 - AmeriWater Heatsan 00HS208: 2018-07-06 Heatsan, 208V, 3 Phase, Heat Disinfection System for Distribution Loops
• 00817927020031 - AmeriWater Heatsan 00HS460: 2018-07-06 Heatsan, 460V, 3 Phase, Heat Disinfection System for Distribution Loops
• 00817927020048 - AmeriWater Heatsan 00HS575: 2018-07-06 Heatsan, 575V, 3 Phase, Heat Disinfection System for Distribution Loops
• 00817927020055 - AmeriWater 00BC55-55 Bicarb Mix and Distribution System: 2018-07-06 Dual Tank Bicarb Mix and Distribution System, 55 Gallon