Catalog Number

-

Brand Name

HealthPatch® MD Gentle Patch

Version/Model Number

1001-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2018

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

-

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Public Device Record Key

a17b074e-b281-4df7-a449-542749f927c6

Public Version Date

August 07, 2019

Public Version Number

4

DI Record Publish Date

August 23, 2016

Package DI Number

00850490007023

Quantity per Package

5

Contains DI Package

00850490007009

Package Discontinue Date

March 31, 2018

Package Status

Not in Commercial Distribution

Package Type

-