Catalog Number

-

Brand Name

Vortex

Version/Model Number

051H7400

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

K020944,K020944

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

74c83109-b459-49bf-8061-af2cd26eae0f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 02, 2017

Package DI Number

00744229510420

Quantity per Package

50

Contains DI Package

00744229510413

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton