Catalog Number

NA

Brand Name

Millenium HX

Version/Model Number

RO,Millenium HX, 750GPD,4118,230~,50HZ

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 23, 2020

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

-

Product Code

FIP

Product Code Name

Subsystem, Water Purification

Public Device Record Key

51fe308b-d1e2-4bf7-a60d-989a11115a8d

Public Version Date

May 27, 2020

Public Version Number

2

DI Record Publish Date

April 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-