FDA.reportPublic FDA data

AmeriWater Heatsan 00HS575

Primary DI
00817927020048
Brand
AmeriWater Heatsan 00HS575
Company
AMERIWATER, LLC
Model
00HS575
Device description
Heatsan, 575V, 3 Phase, Heat Disinfection System for Distribution Loops
Published
2017-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
K142285000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142285000AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hzAmeriwater2014-12-01FIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817927020048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817927020048008179270200488179270200480817927020048

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis water purification system thermal disinfectorAn electrically-powered unit intended to heat water and pump the hot water into the ringline/pipeline of a reverse-osmosis haemodialysis water purification system for cleaning and disinfection. It typically consists of a heater, pump, and connectors.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth0
Height0
Weight0
Width0

Regulatory Flags#

DUNS number
836758342
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817927020024AmeriWater Heatsan 00HS20800HS2082017-01-05
00817927020031AmeriWater Heatsan 00HS46000HS4602017-01-05
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
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
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