Catalog Number

-

Brand Name

MyCite Patch

Version/Model Number

DW5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2021

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

Yes

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

-

FDA Premarket Submission

-

Product Code

DXH

Product Code Name

Transmitters And Receivers, Electrocardiograph, Telephone

Public Device Record Key

8f2d11ac-9309-4416-b1cf-2122ac9a4cd8

Public Version Date

July 04, 2022

Public Version Number

3

DI Record Publish Date

January 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-