Catalog Number

31151882

Brand Name

Kendall

Version/Model Number

31151882

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

2741bed5-aa2d-4e04-b0a3-5f817f55e035

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

30884527008333

Quantity per Package

60

Contains DI Package

20884527008336

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK