Catalog Number

-

Brand Name

Portex

Version/Model Number

101/860/080

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K173384,K173384,K173384

Product Code

BTO

Product Code Name

Tube, tracheostomy (w/wo connector)

Public Device Record Key

fa9a9b24-cd73-442b-b1b1-ced132a4475a

Public Version Date

June 05, 2020

Public Version Number

2

DI Record Publish Date

January 16, 2019

Package DI Number

35019517077937

Quantity per Package

1

Contains DI Package

15019517077933

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

EACH