Catalog Number

-

Brand Name

Portex

Version/Model Number

A4059-17

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"

-

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

K923878,K923878

Product Code

JOH

Product Code Name

Tube tracheostomy and tube cuff

Public Device Record Key

325be2ef-d607-4e82-a8da-992c3fb26f79

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2015

Package DI Number

10351688080554

Quantity per Package

10

Contains DI Package

20351688080551

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON