Catalog Number

-

Brand Name

Portex

Version/Model Number

225-3709-800-NL

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)

-

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

-

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

e43a4473-c239-4c29-86cf-99db73205eb2

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

October 11, 2016

Package DI Number

10351688419439

Quantity per Package

20

Contains DI Package

30351688419433

Package Discontinue Date

September 27, 2019

Package Status

Not in Commercial Distribution

Package Type

Carton