Catalog Number

-

Brand Name

Portex

Version/Model Number

535080

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

JOH

Product Code Name

Tube tracheostomy and tube cuff

Public Device Record Key

16b898d0-c7a8-4619-9bc0-38709df8765d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 29, 2015

Package DI Number

30351688051916

Quantity per Package

2

Contains DI Package

00351688051915

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON