AmeriWater MRO3

GUDID 00817927020222

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

AMERIWATER, LLC

Reverse-osmosis water purification system
Primary Device ID00817927020222
NIH Device Record Keyf61edd71-c4eb-41e8-be05-572bf51e5006
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmeriWater MRO3
Version Model NumberMRO3
Company DUNS836758342
Company NameAMERIWATER, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Height52 Inch
Height52 Inch
Height52 Inch
Height52 Inch
Height52 Inch
Height52 Inch
Height52 Inch
Height52 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100817927020222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FIPSubsystem, Water Purification

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817927020222]

High-level Disinfectant;Peracetic Acid


[00817927020222]

High-level Disinfectant;Peracetic Acid


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-06

Devices Manufactured by AMERIWATER, LLC

00817927020321 - AmeriWater MediQA 00MSP3HF-2302023-06-15 MediQA, Single Pass, 3 Membrane, up to 23,040 GPD, 208/230V, 3 Ph
00817927020338 - AmeriWater Water Purification System for Hemodialysis2023-06-15 AmeriWater Water Purification System for Hemodialysis including reverse osmosis with pre-treatment and post-treatment intended t
00817927020000 - AmeriWater MROS2018-07-06 MROS, Single Patient Portable RO, 730 GPD, 115V
00817927020017 - AmeriWater MRO12018-07-06 MRO1 (1 to 2 Stations Portable RO), 1,400 GPD, 115V
00817927020024 - AmeriWater Heatsan 00HS2082018-07-06 Heatsan, 208V, 3 Phase, Heat Disinfection System for Distribution Loops
00817927020031 - AmeriWater Heatsan 00HS4602018-07-06 Heatsan, 460V, 3 Phase, Heat Disinfection System for Distribution Loops
00817927020048 - AmeriWater Heatsan 00HS5752018-07-06 Heatsan, 575V, 3 Phase, Heat Disinfection System for Distribution Loops
00817927020055 - AmeriWater 00BC55-55 Bicarb Mix and Distribution System2018-07-06 Dual Tank Bicarb Mix and Distribution System, 55 Gallon

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