Catalog Number

-

Brand Name

VitalPatch® Active Biosensor

Version/Model Number

3012-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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,K152139

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Public Device Record Key

d773a8a4-6e1e-4dc3-8f4c-8c0aea3c0f8f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 04, 2017

Package DI Number

00850490007153

Quantity per Package

5

Contains DI Package

00850490007146

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-