Catalog Number

-

Brand Name

Etekcity Non-Contact Infrared Body Thermometer

Version/Model Number

HTD8816C

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

K171888,K171888

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

cc14c847-db73-43e5-83ca-496627bc297c

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

July 10, 2020

Package DI Number

10817915020149

Quantity per Package

40

Contains DI Package

00817915020142

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton