Catalog Number

-

Brand Name

Sweat-Chek™ Sweat Conductivity Analyzer

Version/Model Number

Model 3120

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

K863395

Product Code

CGZ

Product Code Name

Electrode, Ion-Specific, Chloride

Public Device Record Key

8a4e9d78-ddd1-48fe-9954-227457c893b3

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-