Catalog Number

-

Brand Name

Mini Neb

Version/Model Number

NB50

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 07, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

0211f268-abd9-45e2-8476-746c9cf75986

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

March 27, 2020

Package DI Number

14719874690011

Quantity per Package

150

Contains DI Package

04719874690014

Package Discontinue Date

April 07, 2020

Package Status

Not in Commercial Distribution

Package Type

-