Catalog Number

-

Brand Name

MyCite Patch

Version/Model Number

RW2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 31, 2030

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

cf349dc5-f295-4841-82f1-9c55363989a2

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

April 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-