Catalog Number

-

Brand Name

AmeriWater MRO8Z

Version/Model Number

MRO8Z

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K131622

Product Code

FIP

Product Code Name

Subsystem, Water Purification

Public Device Record Key

83323b3b-230f-466c-a8e3-1fb0c89ff9bf

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

-