Catalog Number

664.71

Brand Name

Caring Mill

Version/Model Number

EM44CM Replacement Pads

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132998,K132998

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

ec8dfa6a-d482-4d4b-887b-31d16aa36231

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

January 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-