FDA.reportPublic FDA data

AquaA

Primary DI
04251285200371
Brand
AquaA
Company
VIVONIC GmbH
Model
AquaA 2700H
Device description
The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
Published
2022-08-08
Public version status
Update
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
K213507000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213507000AquaAFresenius Medical Care Rental Therapies Group, LLC2022-07-27FIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251285200371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251285200371042512852003714251285200371

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal115 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341685795
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251285200234AquaCUNO H2016-09-24
04251285200524AquaB LITEAquaB LITE 5002024-07-25
04251285200531AquaB LITEAquaB LITE 10002024-07-25
04251285200548AquaB LITEAquaB LITE 15002024-07-25
04251285200555AquaB LITEAquaB LITE 20002024-07-25
04251285200562AquaB LITEAquaB LITE 25002024-07-25
04251285200579AquaB LITEAquaB LITE 30002024-07-25
04251285200586AquaB LITEB2 LITE 5002024-07-25
04251285200593AquaB LITEB2 LITE 10002024-07-25
04251285200609AquaB LITEB2 LITE 15002024-07-25
04251285200616AquaB LITEB2 LITE 20002024-07-25
04251285200623AquaB LITEB2 LITE 25002024-07-25
04251285200319AquaAAquaA 10002022-08-08
04251285200326AquaAAquaA 20002022-08-08
04251285200333AquaAAquaA 30002022-08-08
04251285200340AquaAAquaA 40002022-08-08
04251285200357AquaAAquaA 900H2022-08-08
04251285200364AquaAAquaA 1800H2022-08-08
04251285200388AquaAAquaA 3600H2022-08-08
04251285200395AquaAAquaA2 10002022-08-08

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