Catalog Number

-

Brand Name

DANZ

Version/Model Number

HTD8219US

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 26, 2021

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

K200781,K200781

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

b3ee5ea6-b2b3-4a3c-9286-7e18bccca052

Public Version Date

April 28, 2021

Public Version Number

2

DI Record Publish Date

February 26, 2021

Package DI Number

16970289035172

Quantity per Package

108

Contains DI Package

06970289035175

Package Discontinue Date

February 26, 2021

Package Status

Not in Commercial Distribution

Package Type

-