Catalog Number

-

Brand Name

PC ECG (Data Management Software)

Version/Model Number

SE-1515

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

f9f58212-0a29-4c89-8cb2-5ee2b7fa49cb

Public Version Date

March 10, 2021

Public Version Number

6

DI Record Publish Date

October 09, 2016

Package DI Number

6944413808300

Quantity per Package

10

Contains DI Package

06944413808294

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-