Catalog Number

INFMASK2

Brand Name

CARDINAL HEALTH

Version/Model Number

INFMASK2

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

CAT

Product Code Name

CANNULA, NASAL, OXYGEN

Public Device Record Key

d9144b61-80dc-40e9-b3e6-a1709ec8ca94

Public Version Date

May 21, 2019

Public Version Number

1

DI Record Publish Date

May 13, 2019

Package DI Number

50885380028661

Quantity per Package

50

Contains DI Package

00885380028666

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE