Catalog Number

MK06200

Brand Name

Kendall

Version/Model Number

MK06200

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"

-

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

DRX

Product Code Name

Electrode, electrocardiograph

Public Device Record Key

c4ce75c8-1498-4829-84d7-ecc0e6c91c08

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

20884527010339

Quantity per Package

20

Contains DI Package

10884527010332

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE