Catalog Number

1200S-D-00U-01

Brand Name

12 lead ECG for rest and stress.

Version/Model Number

PCECG 1200S

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

MWI

Product Code Name

Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Public Device Record Key

7bc4ffed-42de-4e7c-9491-6f49f86adb86

Public Version Date

September 30, 2019

Public Version Number

4

DI Record Publish Date

October 26, 2016

Package DI Number

7290110250843

Quantity per Package

1

Contains DI Package

07290110250812

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton box