Vicks - THERMOMETER, COMFORTFLEX, 8-SEC, DIGITAL INSIGHT - KAZ USA, INC.

Duns Number:122612547

Device Description: THERMOMETER, COMFORTFLEX, 8-SEC, DIGITAL INSIGHT

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More Product Details

Catalog Number

-

Brand Name

Vicks

Version/Model Number

V966USV2

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

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

ef193a33-2405-4092-8b16-ede1eb3f52c4

Public Version Date

October 07, 2020

Public Version Number

1

DI Record Publish Date

September 29, 2020

Additional Identifiers

Package DI Number

20328785004681

Quantity per Package

24

Contains DI Package

00328785004687

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