Vicks - Thermometer, Rectal, Baby - KAZ USA, INC.

Duns Number:122612547

Device Description: Thermometer, Rectal, Baby

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More Product Details

Catalog Number

-

Brand Name

Vicks

Version/Model Number

V934-V

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

K851146,K851146,K851146

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

d68694c5-53a2-4ef2-a2bc-59a217fa0a16

Public Version Date

May 27, 2020

Public Version Number

4

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

10328785000440

Quantity per Package

12

Contains DI Package

00328785000443

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