Catalog Number

-

Brand Name

Portable Mesh Nebulizer

Version/Model Number

Air Mask II

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"

-

For Single-Use

-

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

K182906

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

658c8462-82b7-423a-af77-095a6242d2b1

Public Version Date

August 27, 2021

Public Version Number

1

DI Record Publish Date

August 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-