Catalog Number

140

Brand Name

Advocate Non-Contact Infra-red thermometer

Version/Model Number

140

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

K111703,K111703

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

09b4bd43-3512-428f-8d39-7a7edc96f6bb

Public Version Date

December 07, 2020

Public Version Number

8

DI Record Publish Date

August 22, 2016

Package DI Number

20894046001046

Quantity per Package

18

Contains DI Package

00894046001042

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

140-C