Catalog Number

-

Brand Name

Kaz

Version/Model Number

821-24

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

K851146,K851146

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

738b58d6-7977-499c-ba95-e020a3bb2741

Public Version Date

May 27, 2020

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

10328785000457

Quantity per Package

24

Contains DI Package

00328785000450

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-