Catalog Number

K100-0101B

Brand Name

EZ-Chek

Version/Model Number

K100-0101B

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

K901734,K901734

Product Code

MSY

Product Code Name

Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

Public Device Record Key

83c93615-1751-4077-9f05-3b467f06b14a

Public Version Date

August 16, 2019

Public Version Number

4

DI Record Publish Date

March 07, 2017

Package DI Number

10858293006325

Quantity per Package

6

Contains DI Package

00858293006328

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

package