Catalog Number

5201

Brand Name

ISE Sodium electrode

Version/Model Number

5201

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

K000926

Product Code

JGS

Product Code Name

Electrode, Ion Specific, Sodium

Public Device Record Key

007ac2f9-9f9b-4076-9732-5b84e2c9a66f

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

-