Kendall - KendallH34LG Foam Monitoring electrode with - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: KendallH34LG Foam Monitoring electrode with Liquid gel 50x45mm

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More Product Details

Catalog Number

31.1345.21

Brand Name

Kendall

Version/Model Number

31.1345.21

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

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

cb55475e-238c-45f1-a4b8-ddbedbf5153e

Public Version Date

April 21, 2022

Public Version Number

1

DI Record Publish Date

April 13, 2022

Additional Identifiers

Package DI Number

30192253016868

Quantity per Package

10

Contains DI Package

20192253016861

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"CARDINAL HEALTH 200, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 101686
2 A medical device with a moderate to high risk that requires special controls. 139430
3 A medical device with high risk that requires premarket approval 8
U Unclassified 40