Catalog Number

3801-01

Brand Name

VitalPatch Adhesive Overlay

Version/Model Number

3801-01

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KGX

Product Code Name

Tape And Bandage, Adhesive

Public Device Record Key

af5d0f68-2bb7-454e-b9a2-100f2077bddc

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

March 26, 2019

Package DI Number

00850490007290

Quantity per Package

20

Contains DI Package

00850490007283

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag