Catalog Number

-

Brand Name

RENPHO Infrared Forehead Thermometer

Version/Model Number

DET-306

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

K181239,K181239

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

3ce1e26a-6907-4ac7-a14d-f2e158d4dd61

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

July 23, 2020

Package DI Number

30860002249668

Quantity per Package

100

Contains DI Package

00860002249667

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton