Catalog Number

-

Brand Name

Portex

Version/Model Number

C1123

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)

-

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

6d5d233f-5018-4c72-b9bf-1bc80bb9ca75

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

March 18, 2020

Package DI Number

35019517218149

Quantity per Package

20

Contains DI Package

15019517218145

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag