Catalog Number

02J9422

Brand Name

ARCHITECT

Version/Model Number

2J94-22

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

-

Product Code

CEM

Product Code Name

ELECTRODE, ION SPECIFIC, POTASSIUM

Public Device Record Key

79f051f0-661a-470a-9ba9-a29395cdb2ef

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

October 31, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-