Catalog Number

-

Brand Name

Portex

Version/Model Number

100/503/200

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

-

Product Code

JAY

Product Code Name

SUPPORT, BREATHING TUBE

Public Device Record Key

f245bdb2-0fca-47bd-ab7d-444f1c1e43ad

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

February 12, 2018

Package DI Number

35019315031827

Quantity per Package

10

Contains DI Package

15019315031823

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX