Catalog Number

-

Brand Name

NA

Version/Model Number

Smart ECG Broker

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NSX

Product Code Name

Software, Transmission And Storage, Patient Data

Public Device Record Key

d1112711-0a53-4c34-b68f-8f4e273048bb

Public Version Date

March 10, 2021

Public Version Number

4

DI Record Publish Date

December 03, 2016

Package DI Number

6944413808324

Quantity per Package

10

Contains DI Package

06944413808126

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-