Catalog Number

7005

Brand Name

pH/pCO2/pO2/Na/K/Ca Analyzer

Version/Model Number

7005

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

K021515

Product Code

CEM

Product Code Name

Electrode, Ion Specific, Potassium

Public Device Record Key

e3dbf205-f895-42d8-91a4-e01f1a37927b

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

December 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-