Catalog Number

-

Brand Name

PHOENIX DIAGNOSTICS, INC.

Version/Model Number

E-310

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K013451

Product Code

CEM

Product Code Name

Electrode, Ion Specific, Potassium

Public Device Record Key

7a297491-e21d-4b41-bc26-22bfc763c304

Public Version Date

March 30, 2020

Public Version Number

4

DI Record Publish Date

January 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-