Catalog Number

-

Brand Name

Portex

Version/Model Number

H4021S

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

K790312,K790312,K790312

Product Code

BTR

Product Code Name

Tube, tracheal (w/wo connector)

Public Device Record Key

b21269ae-32f6-406e-b2bb-2b61894f0cc8

Public Version Date

October 08, 2018

Public Version Number

4

DI Record Publish Date

September 01, 2015

Package DI Number

35019315077573

Quantity per Package

10

Contains DI Package

15019315077579

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX