Catalog Number

6201

Brand Name

pH Electrode

Version/Model Number

6201

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

K974526

Product Code

CHL

Product Code Name

Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Public Device Record Key

8849640f-efcb-4a08-bc7b-4a63b2d12d91

Public Version Date

January 07, 2019

Public Version Number

1

DI Record Publish Date

December 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-