Catalog Number

K100-0117

Brand Name

E-Z Chek

Version/Model Number

5116A

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

Yes

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

K101750

Product Code

MNV

Product Code Name

Strip, Dialysate Ph Indicator

Public Device Record Key

5b039332-8820-4c3d-a43a-303e3effdb34

Public Version Date

April 26, 2022

Public Version Number

5

DI Record Publish Date

March 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-