Catalog Number

ECGUSB1A-K-00-01

Brand Name

ECG

Version/Model Number

ECGUSB1

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)

-

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

34e8e183-dc3c-4552-853d-5b031c8e9e11

Public Version Date

September 30, 2019

Public Version Number

3

DI Record Publish Date

October 26, 2016

Package DI Number

7290110253004

Quantity per Package

1

Contains DI Package

07290110250959

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box