Catalog Number

-

Brand Name

Microlife

Version/Model Number

NEB200

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

-

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

45304925-c3b8-43a3-8fe0-a9ed15b7dd4f

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 13, 2020

Package DI Number

10642632472007

Quantity per Package

6

Contains DI Package

00642632472000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-