Catalog Number

AMTOD3CH

Brand Name

CARDINAL HEALTH

Version/Model Number

AMTOD3CH

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

442f5ca9-936c-4d6a-8a41-c215dfc51285

Public Version Date

May 28, 2019

Public Version Number

1

DI Record Publish Date

May 20, 2019

Package DI Number

50885380057937

Quantity per Package

20

Contains DI Package

10885380057939

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE