Catalog Number

-

Brand Name

Portex

Version/Model Number

100/573/000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 16, 2017

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

e193fa3d-e9d8-4488-8bda-609651cb597c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-