Catalog Number

-

Brand Name

Med-link

Version/Model Number

V0012M-A

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

f15735d8-c35f-4eeb-896a-b61f9f75a637

Public Version Date

March 27, 2020

Public Version Number

3

DI Record Publish Date

March 29, 2017

Package DI Number

16944414005583

Quantity per Package

5

Contains DI Package

06944414005586

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag