Catalog Number

-

Brand Name

Langston® dual lumen catheter

Version/Model Number

5515

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

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

32b11c0b-44f1-4562-ba63-71f3910c12fb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 05, 2016

Package DI Number

M20655151

Quantity per Package

5

Contains DI Package

M20655150

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-