Catalog Number

-

Brand Name

Danz

Version/Model Number

HTD8216C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 20, 2020

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

K180385,K180385

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

5d749fe8-90e5-4521-ad1b-4c51b611f40b

Public Version Date

April 28, 2021

Public Version Number

4

DI Record Publish Date

August 20, 2020

Package DI Number

16970289035042

Quantity per Package

84

Contains DI Package

06970289035045

Package Discontinue Date

August 20, 2020

Package Status

Not in Commercial Distribution

Package Type

-