Catalog Number

-

Brand Name

Infusion Catheter

Version/Model Number

MC3L-6S

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

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

FOZ

Product Code Name

Catheter,intravascular,therapeutic,short-term less than 30 days

Public Device Record Key

416ee446-db3b-4a9c-8843-daeab641c559

Public Version Date

July 15, 2022

Public Version Number

8

DI Record Publish Date

October 23, 2015

Package DI Number

50884908028947

Quantity per Package

10

Contains DI Package

00884908028942

Package Discontinue Date

January 29, 2021

Package Status

Not in Commercial Distribution

Package Type

box