Catalog Number

-

Brand Name

Magnair

Version/Model Number

578G8200

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

94810edd-cad9-4be8-9454-a9cb9437bb01

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 26, 2017

Package DI Number

00744229578079

Quantity per Package

12

Contains DI Package

00744229578055

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton