Catalog Number

-

Brand Name

Portex

Version/Model Number

100/541/090CZ

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

K060945,K060945,K060945

Product Code

BTO

Product Code Name

Tube, tracheostomy (w/wo connector)

Public Device Record Key

ff2e3575-0f05-422f-bccd-fbc56237ef3f

Public Version Date

October 16, 2018

Public Version Number

4

DI Record Publish Date

April 04, 2016

Package DI Number

35019315106617

Quantity per Package

1

Contains DI Package

15019315106613

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box