Catalog Number

-

Brand Name

Philips ear thermometer

Version/Model Number

DL8740

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

K100488,K100488

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

44a2b7b1-6ba0-4289-839c-a98f96676f65

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

20075020053309

Quantity per Package

4

Contains DI Package

00075020054043

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-