AmeriWater MROS

GUDID 00817927020000

MROS, Single Patient Portable RO, 730 GPD, 115V

AMERIWATER, LLC

Reverse-osmosis water purification system

• Primary Device ID: 00817927020000
• NIH Device Record Key: 8c0a38d8-e28a-4818-ad35-655d07cf0fb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AmeriWater MROS
• Version Model Number: MROS
• 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 Dimensions

• Height: 47 Inch
• Height: 47 Inch
• Height: 47 Inch
• Height: 47 Inch
• Height: 47 Inch
• Height: 47 Inch
• Height: 47 Inch
• Height: 47 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817927020000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111740

FDA Product Code

• FIP: Subsystem, Water Purification

Sterilization

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

[00817927020000]

Peracetic Acid;High-level Disinfectant

[00817927020000]

Peracetic Acid;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-05

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: 2023-06-15 AmeriWater Water Purification System for Hemodialysis including reverse osmosis with pre-treatment and post-treatment intended t
• 00817927020000 - AmeriWater MROS: 2018-07-06MROS, Single Patient Portable RO, 730 GPD, 115V
• 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