AquaA - Additional heating unit for AquaA water - VIVONIC GmbH

Duns Number:341685795

Device Description: Additional heating unit for AquaA water purification system.AquaHT for:AquaA 900H & AquaHT Additional heating unit for AquaA water purification system.AquaHT for:AquaA 900H & AquaHTAquaA 1800H & AquaA2 900H & AquaHTAquaA 1800H & AquaHTAquaA 1800H & AquaA2 1800H & AquaHTAquaA 2700H & AquaHTAquaA 2700H & AquaA2 2700H & AquaHTAquaA 3600H & AquaHTAquaA 3600H & AquaA2 3600H & AquaHTThe 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.

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More Product Details

Catalog Number

-

Brand Name

AquaA

Version/Model Number

AquaHT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K213507

Product Code Details

Product Code

FIP

Product Code Name

Subsystem, Water Purification

Device Record Status

Public Device Record Key

dc2f7ce7-3117-4bd6-bf39-3f0911838d77

Public Version Date

August 16, 2022

Public Version Number

1

DI Record Publish Date

August 08, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VIVONIC GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 50