Catalog Number

-

Brand Name

Vicks

Version/Model Number

VBR-5

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

Yes

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

4f794085-f20a-45d8-9a33-5a6a3678618d

Public Version Date

May 27, 2020

Public Version Number

2

DI Record Publish Date

September 28, 2018

Package DI Number

20328785100055

Quantity per Package

12

Contains DI Package

00328785100051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE