Catalog Number

-

Brand Name

Portex

Version/Model Number

100/856/085

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

-

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

K030381,K030381,K030381

Product Code

BTO

Product Code Name

Tube, tracheostomy (w/wo connector)

Public Device Record Key

4cf50a0e-6842-45d6-a8ea-3fa746490544

Public Version Date

December 08, 2020

Public Version Number

4

DI Record Publish Date

September 01, 2015

Package DI Number

35019315052631

Quantity per Package

20

Contains DI Package

15019315052637

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case