Catalog Number

-

Brand Name

Portex

Version/Model Number

100/595/080

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JOH

Product Code Name

Tube tracheostomy and tube cuff

Public Device Record Key

ac9f489f-7734-4573-918d-4528307fe950

Public Version Date

November 12, 2019

Public Version Number

1

DI Record Publish Date

November 04, 2019

Package DI Number

30351688072126

Quantity per Package

2

Contains DI Package

00351688072125

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton