Catalog Number

-

Brand Name

CareFusion

Version/Model Number

2009110-150

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"

Yes

For Single-Use

Yes

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

K020003,K020003

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

345469c7-8948-444e-904d-3a9a1dbfbd95

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 10, 2018

Package DI Number

18809083941533

Quantity per Package

500

Contains DI Package

08809083941536

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box