Catalog Number

-

Brand Name

Med-link

Version/Model Number

V0010G

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"

Yes

For Single-Use

-

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

e38c6c69-1f48-416b-8130-415302568426

Public Version Date

March 27, 2020

Public Version Number

3

DI Record Publish Date

March 19, 2017

Package DI Number

16944414031711

Quantity per Package

20

Contains DI Package

06944414031714

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag