Catalog Number

989803171801

Brand Name

ECG Electrodes

Version/Model Number

989803171801

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DSI

Product Code Name

DETECTOR AND ALARM, ARRHYTHMIA

Public Device Record Key

7ec3e923-30d7-4be0-989a-bccd9d4aa43c

Public Version Date

November 24, 2021

Public Version Number

5

DI Record Publish Date

March 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-