Catalog Number

U22-5

Brand Name

AC Adapter for Vibrating Mesh Nubulizer NE-U22V

Version/Model Number

U22-5

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K062263

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

e2b68b88-2895-4690-96c9-e88074932ce0

Public Version Date

July 22, 2021

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-