Catalog Number

4103-0000

Brand Name

EasyElectrolyte Reagent Module, Na/K/Li Analyzers

Version/Model Number

4103-0000

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

K002407

Product Code

CEM

Product Code Name

Electrode, Ion Specific, Potassium

Public Device Record Key

d71c1089-853e-4439-ab92-348b3522d092

Public Version Date

January 11, 2019

Public Version Number

1

DI Record Publish Date

December 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-