AmeriWater 00BC100-200 Bicarb Mix and Distribution System

GUDID 00817927020079

Dual Tank Bicarb Mix and Distribution System, 185 Gallon

AMERIWATER, LLC

Haemodialysis system bicarbonate mixer

• Primary Device ID: 00817927020079
• NIH Device Record Key: 62520e93-6eb1-4ca1-950a-eb68694d09f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AmeriWater 00BC100-200 Bicarb Mix and Distribution System
• Version Model Number: 00BC100-200
• 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	00817927020079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051031

FDA Product Code

• FIN: Tank, Holding, Dialysis

Sterilization

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

[00817927020079]

Liquid Chemical;Ozone;High-level Disinfectant

[00817927020079]

Liquid Chemical;Ozone;High-level Disinfectant

[00817927020079]

Liquid Chemical;Ozone;High-level Disinfectant

[00817927020079]

Liquid Chemical;Ozone;High-level Disinfectant

[00817927020079]

Liquid Chemical;Ozone;High-level Disinfectant

[00817927020079]

Liquid Chemical;Ozone;High-level Disinfectant

[00817927020079]

Liquid Chemical;Ozone;High-level Disinfectant

[00817927020079]

Liquid Chemical;Ozone;High-level Disinfectant

[00817927020079]

Liquid Chemical;Ozone;High-level Disinfectant

[00817927020079]

Liquid Chemical;Ozone;High-level Disinfectant

[00817927020079]

Liquid Chemical;Ozone;High-level Disinfectant

[00817927020079]

Liquid Chemical;Ozone;High-level Disinfectant

[00817927020079]

Liquid Chemical;Ozone;High-level Disinfectant

[00817927020079]

Liquid Chemical;Ozone;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

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• 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