Catalog Number

5205

Brand Name

ISE Lithium Electrode

Version/Model Number

5205

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

JIH

Product Code Name

Flame Photometry, Lithium

Public Device Record Key

6830ea9f-4680-4fc9-8552-055ce5f8e0d9

Public Version Date

March 19, 2021

Public Version Number

2

DI Record Publish Date

December 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-