Catalog Number

-

Brand Name

Portex

Version/Model Number

C4510753

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)

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

c501f65a-97ff-48f3-869a-cbd4763019f9

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

January 03, 2017

Package DI Number

30351688422808

Quantity per Package

12

Contains DI Package

10351688422804

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON