Catalog Number

-

Brand Name

Vortex

Version/Model Number

051F7000

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

865c5b8e-a015-43dc-8e53-21ec6baa62d7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 02, 2017

Package DI Number

00744229510369

Quantity per Package

12

Contains DI Package

00744229510352

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton