Catalog Number

-

Brand Name

Vicks

Version/Model Number

V745A

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)

Yes

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

f4dca277-987c-4114-8d9b-dd546f619900

Public Version Date

May 27, 2020

Public Version Number

3

DI Record Publish Date

November 30, 2017

Package DI Number

70328785207452

Quantity per Package

6

Contains DI Package

00328785207453

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case