Catalog Number

-

Brand Name

SMARTHEART

Version/Model Number

01-521

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 23, 2022

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

17c4412a-0acc-4652-92b7-12d68e0d200d

Public Version Date

August 24, 2022

Public Version Number

4

DI Record Publish Date

February 13, 2019

Package DI Number

10845717009376

Quantity per Package

48

Contains DI Package

00845717009379

Package Discontinue Date

August 23, 2022

Package Status

Not in Commercial Distribution

Package Type

-