Catalog Number

-

Brand Name

Portex

Version/Model Number

100/541/180

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

K060945,K060945

Product Code

BTO

Product Code Name

Tube, tracheostomy (w/wo connector)

Public Device Record Key

4bdbd94c-f573-47e8-95f0-87e744cdc2f0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2015

Package DI Number

35019315075203

Quantity per Package

2

Contains DI Package

15019315075209

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON