Catalog Number

615004

Brand Name

Multi-Track™

Version/Model Number

615004

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 11, 2021

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

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

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Public Device Record Key

e5fc9e97-601f-47ea-a0cd-05345a1ff855

Public Version Date

March 15, 2021

Public Version Number

4

DI Record Publish Date

August 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-