Catalog Number

3035-01

Brand Name

VitalPatch™ 2.0 Single

Version/Model Number

3035-01

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

K183078,K183078

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Public Device Record Key

79788e5f-7be5-4efa-a209-28b14ac2b03e

Public Version Date

March 26, 2019

Public Version Number

1

DI Record Publish Date

March 18, 2019

Package DI Number

00850490007221

Quantity per Package

20

Contains DI Package

00850490007214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box