Catalog Number

-

Brand Name

Portex

Version/Model Number

321215

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 27, 2019

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

CBN

Product Code Name

APPARATUS, GAS-SCAVENGING

Public Device Record Key

2a9dbc65-2151-4ed6-a5e5-5d74b59c31a3

Public Version Date

October 15, 2019

Public Version Number

3

DI Record Publish Date

December 28, 2016

Package DI Number

30351688404354

Quantity per Package

15

Contains DI Package

10351688404350

Package Discontinue Date

September 27, 2019

Package Status

Not in Commercial Distribution

Package Type

Box