Catalog Number

2120

Brand Name

Na/K Solution Pack

Version/Model Number

2120

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

K864872

Product Code

CEM

Product Code Name

Electrode, Ion Specific, Potassium

Public Device Record Key

d136d9c1-df43-4c1e-82d4-76e89ba7732b

Public Version Date

January 04, 2019

Public Version Number

1

DI Record Publish Date

December 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-