Catalog Number

-

Brand Name

CVS Health

Version/Model Number

456218

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

Yes

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

K133723,K133723,K133723

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

0ab4cbf5-26a5-4546-8409-2673ee5f698e

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20050428514454

Quantity per Package

4

Contains DI Package

10050428514457

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case