Catalog Number

989803106331

Brand Name

NA

Version/Model Number

989803106331

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 15, 2018

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

DSI

Product Code Name

DETECTOR AND ALARM, ARRHYTHMIA

Public Device Record Key

3ad84ff1-76b4-4a3c-a163-a08bfe847bd0

Public Version Date

November 24, 2021

Public Version Number

5

DI Record Publish Date

February 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-