Catalog Number

CT-1004-00-00

Brand Name

EPOC BGEM TEST CARD

Version/Model Number

CT-1004-00-00

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)

-

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

d5dc330e-6b1b-42b4-a54f-38ea2546a2d8

Public Version Date

November 19, 2021

Public Version Number

5

DI Record Publish Date

August 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-