Catalog Number

-

Brand Name

Portex

Version/Model Number

W1138

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 23, 2015

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

78c80481-7c1f-49b8-ba9f-b5b97543ac61

Public Version Date

October 21, 2020

Public Version Number

3

DI Record Publish Date

October 21, 2015

Package DI Number

30351688074571

Quantity per Package

20

Contains DI Package

20351688074574

Package Discontinue Date

July 31, 2015

Package Status

Not in Commercial Distribution

Package Type

CARTON