FDA.reportPublic FDA data

AmeriWater® Alarm Panel

Primary DI
00817927020413
Brand
AmeriWater® Alarm Panel
Company
AMERIWATER, LLC
Model
00850253
Catalog number
00850253
Device description
AmeriWater® Alarm Panel - Base Model & Remote (R/O Alarm, Low Storage Tank, Low Bicarb, Conductivity, Resistivity and Dump Valve)
Published
2026-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FIPSubsystem, Water Purification

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIPSubsystem, Water PurificationGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121022000AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIVAmeriwater2012-09-17FIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817927020413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817927020413008179270204138179270204130817927020413

GMDN Terms#

Term, Definition table
TermDefinition
Reverse-osmosis water purification systemAn assembly of devices designed to remove unwanted contaminants (bacteria, viruses, chemicals, dissolved substances) from water using osmotic pressure applied to one side of a selective membrane. The system removes ions, large molecules (e.g. proteins, glucose, urea, salts) and other particles from solution by forcing water at high pressure through a membrane containing pores just big enough (e.g., 0.0005 microns) to permit passage of small molecules and water, whilst the contaminants are flushed to waste.

Regulatory Flags#

DUNS number
836758342
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817927020345AmeriWater Chemical Feed System0084-00050084-00052026-05-08
00817927020352AmeriWater Chemical Feed System0084-00060084-00062026-05-08
00817927020369AmeriWater Chemical Feed System0084-00070084-00072026-05-08
00817927020376AmeriWater Chemical Feed System0084-00220084-00222026-05-08
00817927020383AmeriWater® Alarm Panel00850250008502502026-05-08
00817927020390AmeriWater® Alarm Panel00850251008502512026-05-08
00817927020406AmeriWater® Alarm Panel00850252008502522026-05-08
00817927020024AmeriWater Heatsan 00HS20800HS2082017-01-05
00817927020031AmeriWater Heatsan 00HS46000HS4602017-01-05
00817927020048AmeriWater Heatsan 00HS57500HS5752017-01-05
00817927020321AmeriWater MediQA 00MSP3HF-23000MSP3HF-2302023-06-07
00817927020338AmeriWater Water Purification System for HemodialysisComplete System2023-06-07
00817927020055AmeriWater 00BC55-55 Bicarb Mix and Distribution System00BC55-552017-01-05
00817927020062AmeriWater 00BC100-100 Bicarb Mix and Distribution System00BC100-1002017-01-05
00817927020079AmeriWater 00BC100-200 Bicarb Mix and Distribution System00BC100-2002017-01-05
00817927020284AmeriWater 00BCM5500BCM552017-01-10
00817927020291AmeriWater 00BCM10000BCM1002017-01-10
00817927020307AmeriWater 00BCMD5500BCMD552017-01-10
00817927020314AmeriWater 00BCMD10000BCMD1002017-01-10
00817927020000AmeriWater MROSMROS2017-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817927020345AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020352AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020369AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020376AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020383AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020390AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020406AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
04039361261313DIASAFE®plusUSFresenius Medical Care AGFIP2026-05-01
00850001011266Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
00850001011341Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
00850001011358Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
00860008016942Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016973Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016904Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016911Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016928Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016959Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016966Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
RO0258E-2436RO, 8640GPD, 208V, 4MEMBETTER WATER, LLCFIP2024-11-13
PB0002MEDI-PORT PBII R.O. 220VBETTER WATER, LLCFIP2024-11-13
PB0003MEDI-PORT PBII R.O. 120VBETTER WATER, LLCFIP2024-11-13
PR0023"PRETREAT, 1"", 208V, CPVC, SHORT, AC"BETTER WATER, LLCFIP2024-11-13
PS0155"POST-TREAT, .03 30"", 208V"BETTER WATER, LLCFIP2024-11-13
04251285200524AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200531AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200548AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200555AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200562AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200579AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200586AquaB LITEVIVONIC GmbHFIP2024-07-25