Catalog Number

-

Brand Name

Vicks

Version/Model Number

V4600V2

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KFZ

Product Code Name

Humidifier, Non-Direct Patient Interface (Home-Use)

Public Device Record Key

c94e86ad-4b60-4fff-8f47-d9470a8307ea

Public Version Date

May 27, 2020

Public Version Number

2

DI Record Publish Date

April 03, 2020

Package DI Number

10328785004820

Quantity per Package

2

Contains DI Package

00328785004823

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE