Catalog Number

-

Brand Name

Portex

Version/Model Number

6970

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

-

Product Code

BTO

Product Code Name

Tube, tracheostomy (w/wo connector)

Public Device Record Key

8e98ca5f-0e95-44d7-baf0-7c520bdcc66a

Public Version Date

October 21, 2020

Public Version Number

3

DI Record Publish Date

September 01, 2015

Package DI Number

30351688023173

Quantity per Package

20

Contains DI Package

20351688023176

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON