Kendall - 935 Foam Electrodes,Conductive Adhesive Hydrogel, - Cardinal Health, Inc.

Duns Number:080935429

Device Description: 935 Foam Electrodes,Conductive Adhesive Hydrogel, Radiolucent

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More Product Details

Catalog Number

22935

Brand Name

Kendall

Version/Model Number

22935

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 01, 2023

Issuing Agency

In GS1

Product Characteristics

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

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

-

Product Code Details

Product Code

DRX

Product Code Name

Electrode, electrocardiograph

Device Record Status

Public Device Record Key

48218e26-aba6-48df-9de0-029417291023

Public Version Date

October 08, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

30884521170593

Quantity per Package

600

Contains DI Package

10884521170599

Package Discontinue Date

July 01, 2023

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 672
2 A medical device with a moderate to high risk that requires special controls. 1692
U Unclassified 17