POSTTREAT, .03 30", 208V - Wall-mounted post-treatment for water - BETTER WATER, LLC

Duns Number:055252159

Device Description: Wall-mounted post-treatment for water purification for dialysis applications. Includes one Wall-mounted post-treatment for water purification for dialysis applications. Includes one .03 30" filter, and two pumps. 208V.

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More Product Details

Catalog Number

WM-PST-303-00-2GJ

Brand Name

POSTTREAT, .03 30", 208V

Version/Model Number

WM-PST-303-00-2GJ

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K920186

Product Code Details

Product Code

FIP

Product Code Name

Subsystem, Water Purification

Device Record Status

Public Device Record Key

cf4a0fa3-1d8b-4588-99b5-a387a52c2107

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 13, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BETTER WATER, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 77