Catalog Number

-

Brand Name

Portex

Version/Model Number

C1036J

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

75eb1285-5ab3-4b65-9a09-6b583305c149

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

October 05, 2017

Package DI Number

35019315059579

Quantity per Package

20

Contains DI Package

05019315059578

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON