AmeriWater MediQA 00MDP4-230

GUDID 00817927020130

MediQA, Double Pass, 4 Membrane, up to 14,400 GPD, 208/230V, 3 Ph

AMERIWATER, LLC

Reverse-osmosis water purification system
Primary Device ID00817927020130
NIH Device Record Key17923d12-e0af-4031-ac9f-a4623d8c439b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmeriWater MediQA 00MDP4-230
Version Model Number00MDP4-230
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

Depth76 Inch
Depth76 Inch
Depth76 Inch
Depth76 Inch
Depth76 Inch
Depth76 Inch
Depth76 Inch
Depth76 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100817927020130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FIPSubsystem, Water Purification

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817927020130]

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


[00817927020130]

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


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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.