Catalog Number

-

Brand Name

Ultrasonic Mini Nebulizer

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Product Code

CCQ

Product Code Name

Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Public Device Record Key

8b895f87-1b5a-4e74-8b42-3c04675e7682

Public Version Date

September 30, 2022

Public Version Number

1

DI Record Publish Date

September 22, 2022

Package DI Number

10850027494361

Quantity per Package

32

Contains DI Package

00850027494364

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton