Catalog Number

HH-1009-CA-00

Brand Name

EPOC HOST 2, CA

Version/Model Number

HH-1009-CA-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

-

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

0f13d0fe-62db-4abb-8277-93b06d687a47

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

July 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-