Catalog Number

-

Brand Name

Portex

Version/Model Number

37101171

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

BSJ

Product Code Name

MASK, GAS, ANESTHETIC

Public Device Record Key

8f233ff2-a43d-4859-9891-3d5dfb46bbf2

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

October 11, 2016

Package DI Number

30351688433125

Quantity per Package

15

Contains DI Package

10351688433121

Package Discontinue Date

September 27, 2019

Package Status

Not in Commercial Distribution

Package Type

Carton