Catalog Number

-

Brand Name

SWIVEL AEROSOL MASK, CHILD

Version/Model Number

OM-82220

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

BYG

Product Code Name

Mask, Oxygen

Public Device Record Key

a468c8c0-ca01-4c03-a1c3-7da7a7358711

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

December 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-