Catalog Number

-

Brand Name

Portex

Version/Model Number

482804

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

da7a0c5d-855d-47bd-901d-74b13fcb412b

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

October 05, 2016

Package DI Number

30351688423867

Quantity per Package

40

Contains DI Package

10351688423863

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON