AmeriWater Centurion Reverse Osmosis System

GUDID 00817927020147

Centurion, Single Patient Heat Disinfect RO, 1500 ml/minute, 115V, 1 Ph

AMERIWATER, LLC

Reverse-osmosis water purification system
Primary Device ID00817927020147
NIH Device Record Keyb61ca25b-40a1-4343-8491-7bd7259f05ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmeriWater Centurion Reverse Osmosis System
Version Model Number00MROC
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

Width11 Inch
Width11 Inch
Width11 Inch
Width11 Inch
Width11 Inch
Width11 Inch
Width11 Inch
Width11 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100817927020147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FIPSubsystem, Water Purification

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817927020147]

Moist Heat or Steam Sterilization;High-level Disinfectant;Peracetic Acid


[00817927020147]

Moist Heat or Steam Sterilization;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

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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
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