Catalog Number

CHS230R-WF

Brand Name

Clinical Health Services, Inc.

Version/Model Number

CHS230R-WF

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160138,K160138,K160138,K160138

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

0e552809-542f-4d1b-8cdf-1d64e64d53d4

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

March 08, 2018

Package DI Number

00815290016125

Quantity per Package

8

Contains DI Package

00815290016118

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case