Catalog Number

-

Brand Name

AmeriWater 0077-0010 Ozone Disinfection System

Version/Model Number

0077-0010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141213

Product Code

FIN

Product Code Name

Tank, Holding, Dialysis

Public Device Record Key

ae0df625-c029-47fd-baa3-a1ee61938abd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-