FDA.reportPublic FDA data

AmeriWater Water Purification System for Hemodialysis

Primary DI
00817927020338
Brand
AmeriWater Water Purification System for Hemodialysis
Company
AMERIWATER, LLC
Model
Complete System
Device description
AmeriWater Water Purification System for Hemodialysis including reverse osmosis with pre-treatment and post-treatment intended to produce water that meets all current AAMI and Federal (U.S.) standards for water used in hemodialysis.
Published
2023-06-07
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
K991519000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991519000AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSISAmeriwater2000-04-14FIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817927020338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817927020338008179270203388179270203380817927020338

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.

Sterilization Methods#

Method table
Method
"[""High-level Disinfectant"", ""Peracetic Acid"", ""Moist Heat or Steam Sterilization""]"
High-level Disinfectant;Peracetic Acid;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
836758342
Device count
1
Serial number
true
Sterilization required before use
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
00817927020413AmeriWater® Alarm Panel00850253008502532026-05-08
00817927020024AmeriWater Heatsan 00HS20800HS2082017-01-05
00817927020031AmeriWater Heatsan 00HS46000HS4602017-01-05
00817927020048AmeriWater Heatsan 00HS57500HS5752017-01-05
00817927020321AmeriWater MediQA 00MSP3HF-23000MSP3HF-2302023-06-07
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
00817927020413AmeriWater® 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