Catalog Number

-

Brand Name

"VitalPatch™ Active Patch

Version/Model Number

3002-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2017

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K152139,K152139

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Public Device Record Key

8cbc9e67-931b-4bab-af76-37dbd070d93c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 23, 2016

Package DI Number

00850490007085

Quantity per Package

5

Contains DI Package

00850490007078

Package Discontinue Date

April 30, 2017

Package Status

Not in Commercial Distribution

Package Type

-