Vicks - HUMIDIFIER, COOL MOISTURE, STARRY NIGHT, VICKS, - KAZ USA, INC.

Duns Number:122612547

Device Description: HUMIDIFIER, COOL MOISTURE, STARRY NIGHT, VICKS, GREEN, VELVET PACKAGING

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More Product Details

Catalog Number

-

Brand Name

Vicks

Version/Model Number

V3700G

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

KFZ

Product Code Name

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

Device Record Status

Public Device Record Key

cc8d451c-d0e6-401e-bd8a-a69e3d9d15ea

Public Version Date

May 27, 2020

Public Version Number

3

DI Record Publish Date

December 08, 2017

Additional Identifiers

Package DI Number

70328785347004

Quantity per Package

2

Contains DI Package

00328785347005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"KAZ USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 97
2 A medical device with a moderate to high risk that requires special controls. 22