CARDINAL HEALTH - Monitoring Electrode, Resting Tab - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Monitoring Electrode, Resting Tab

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

ERT100LC

Brand Name

CARDINAL HEALTH

Version/Model Number

ERT100LC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2019

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"

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

K040784,K040784,K040784

Product Code Details

Product Code

DRX

Product Code Name

Electrode, electrocardiograph

Device Record Status

Public Device Record Key

a97f655d-c261-4034-afa5-f4593a8d0d09

Public Version Date

July 01, 2019

Public Version Number

6

DI Record Publish Date

August 17, 2016

Additional Identifiers

Package DI Number

50885380048423

Quantity per Package

10

Contains DI Package

20885380048422

Package Discontinue Date

July 01, 2019

Package Status

Not in Commercial Distribution

Package Type

CASE

"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