Catalog Number

EF001S

Brand Name

ADVOCATE Thermometer Non-contact Infrared

Version/Model Number

141-S

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

11709824-2d0c-4471-bed2-0046c2b6ef63

Public Version Date

December 30, 2021

Public Version Number

6

DI Record Publish Date

December 04, 2019

Package DI Number

10852982006771

Quantity per Package

15

Contains DI Package

00852982006774

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

141-S-C