Catalog Number

-

Brand Name

Carbon Filter Tank

Version/Model Number

K-A-MT-4M57-620-W

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

395f2ef5-f8b5-42df-972d-6c4ad9aba9fa

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-