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) (8) Tank, Holding, Dialysis (FIN) (2)

Premarket Exempt

Clear

AmeriWater MRO8Z - 00817927020208 Catalog Number :

Device Description : MRO8Z, 8 Membrane Reverse Osmosis System, up to 17,600 GPD, 208V, 230V, or 460V 3Ph

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

AmeriWater MRO2 - 00817927020215 Catalog Number :

Device Description : MRO2, Up to Five Stations Portable RO, 2,200 GPD, 115V

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

AmeriWater MRO3 - 00817927020222 Catalog Number :

Device Description : MRO3, 3 Membrane Central RO, 4,200 GPD, 230V 1Ph; 208V, 230V, or 460V 3Ph

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

AmeriWater MRO4 - 00817927020239 Catalog Number :

Device Description : MRO4, 4 Membrane Central RO, 5,600 GPD, 230V 1Ph; 208V, 230V, or 460V 3Ph

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

AmeriWater MRO2X - 00817927020246 Catalog Number :

Device Description : MRO2X, 2 Membrane Central RO, 4,320 GPD, 230V 1Ph; 208V, 230V, or 460V 3Ph

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

AmeriWater MRO3X - 00817927020253 Catalog Number :

Device Description : MRO3X, 3 Membrane Central RO, 5,544 GPD, 230V 1Ph; 208V, 230V, or 460V 3Ph

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

AmeriWater MRO4X - 00817927020260 Catalog Number :

Device Description : MRO4X, 4 Membrane Central RO, 7,401 GPD, 230V 1Ph; 208V, 230V, or 460V 3Ph

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

AmeriWater MRO5X - 00817927020277 Catalog Number :

Device Description : MRO5X, 5 Membrane Central RO, 9,244 GPD, 230V 1Ph; 208V, 230V, or 460V 3Ph

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIP

Prescription Use : Yes

Device Count : 1

AmeriWater 00BCM55 - 00817927020284 Catalog Number :

Device Description : 00BCM55 Manual Mix and Dispense Bicarb, 55 Gallon

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIN

Prescription Use : Yes

Device Count : 1

AmeriWater 00BCM100 - 00817927020291 Catalog Number :

Device Description : 00BCM100 Manual Mix and Dispense Bicarb, 100 Gallon

Device Class : 2

Duns Number: 836758342

Premarket Exempt : No

Product Code : FIN

Prescription Use : Yes

Device Count : 1

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