Catalog Number

-

Brand Name

Portex

Version/Model Number

597080

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

K922749,K922749

Product Code

BTO

Product Code Name

Tube, tracheostomy (w/wo connector)

Public Device Record Key

7e652d10-04ca-41b8-b511-2aaa78f9d53e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 29, 2015

Package DI Number

10351688038715

Quantity per Package

10

Contains DI Package

00351688038718

Package Discontinue Date

July 31, 2015

Package Status

Not in Commercial Distribution

Package Type

BOX