Catalog Number

944-135

Brand Name

Crea Calibration Solution 1

Version/Model Number

944-135

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

Yes

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

4eeb51a0-44c5-4cfa-ac5a-82c3583922b2

Public Version Date

November 27, 2020

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

15700699441352

Quantity per Package

6

Contains DI Package

05700699441355

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-