AMERIWATER, LLC

Address:3345 Stop 8 Rd,DAYTON,OH,45414,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Subsystem, Water Purification (FIP) (6) Tank, Holding, Dialysis (FIN) (4)

Premarket Exempt

Clear

AmeriWater MROS - 00817927020000 Catalog Number :

Device Description : MROS, Single Patient Portable RO, 730 GPD, 115V

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

AmeriWater MRO1 - 00817927020017 Catalog Number :

Device Description : MRO1 (1 to 2 Stations Portable RO), 1,400 GPD, 115V

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

AmeriWater Heatsan 00HS208 - 00817927020024 Catalog Number :

Device Description : Heatsan, 208V, 3 Phase, Heat Disinfection System for Distribution Loops

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIP

Prescription Use : No

Device Count : 1

AmeriWater Heatsan 00HS460 - 00817927020031 Catalog Number :

Device Description : Heatsan, 460V, 3 Phase, Heat Disinfection System for Distribution Loops

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIP

Prescription Use : No

Device Count : 1

AmeriWater Heatsan 00HS575 - 00817927020048 Catalog Number :

Device Description : Heatsan, 575V, 3 Phase, Heat Disinfection System for Distribution Loops

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIP

Prescription Use : No

Device Count : 1

AmeriWater 00BC55-55 Bicarb Mix and Distribution System - 00817927020055 Catalog Number :

Device Description : Dual Tank Bicarb Mix and Distribution System, 55 Gallon

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIN

Prescription Use : Yes

Device Count : 1

AmeriWater 00BC100-100 Bicarb Mix and Distribution System - 00817927020062 Catalog Number :

Device Description : Dual Tank Bicarb Mix and Distribution System, 100 Gallon

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIN

Prescription Use : Yes

Device Count : 1

AmeriWater 00BC100-200 Bicarb Mix and Distribution System - 00817927020079 Catalog Number :

Device Description : Dual Tank Bicarb Mix and Distribution System, 185 Gallon

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIN

Prescription Use : Yes

Device Count : 1

AmeriWater 0077-0010 Ozone Disinfection System - 00817927020086 Catalog Number :

Device Description : Portable Ozone Disinfection System for water storage tanks and bicarb systems.

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIN

Prescription Use : No

Device Count : 1

AmeriWater MediQA 00MSP1-230 - 00817927020093 Catalog Number :

Device Description : MediQA, Single Pass, 1 Membrane, up to 6,480 GPD, 208/230V, 3 Ph

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

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