Catalog Number

-

Brand Name

Med-link

Version/Model Number

EA007C5A

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

K120010,K120010

Product Code

DSA

Product Code Name

Cable, Transducer And Electrode, Patient, (Including Connector)

Public Device Record Key

584c16ca-9c94-42d5-ab26-e6eb2e104de2

Public Version Date

March 27, 2020

Public Version Number

4

DI Record Publish Date

March 29, 2017

Package DI Number

16944414000847

Quantity per Package

20

Contains DI Package

06944414000840

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag