Catalog Number

-

Brand Name

TekCare Infrared Thermometer

Version/Model Number

TS46

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

ef7d745c-4e61-4bad-841f-22428149acfe

Public Version Date

January 31, 2019

Public Version Number

1

DI Record Publish Date

December 31, 2018

Package DI Number

04710953421321

Quantity per Package

40

Contains DI Package

04710953421314

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-