Catalog Number

-

Brand Name

Portex

Version/Model Number

100/597/080CZ

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

BTO

Product Code Name

Tube, tracheostomy (w/wo connector)

Public Device Record Key

46859b9f-68e6-4d9c-8b0e-f64769f9835e

Public Version Date

October 16, 2018

Public Version Number

3

DI Record Publish Date

April 04, 2016

Package DI Number

55019315107144

Quantity per Package

4

Contains DI Package

35019315107140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case