Catalog Number

TD-1261

Brand Name

Qardio Forehead thermometer

Version/Model Number

TD-1261

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)

-

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

f6ef977e-ce52-4a02-a58b-4dcd168cbf70

Public Version Date

January 18, 2021

Public Version Number

1

DI Record Publish Date

January 08, 2021

Package DI Number

10854894005422

Quantity per Package

64

Contains DI Package

00854894005425

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-