Catalog Number

-

Brand Name

SeemtraMed Infrared Thermometer

Version/Model Number

EF 100A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 10, 2019

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

K160802,K160802

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

51fb734a-fb51-40c8-bfc4-acb246cc74c5

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

May 09, 2019

Package DI Number

50860001625818

Quantity per Package

60

Contains DI Package

00860001625813

Package Discontinue Date

May 10, 2019

Package Status

Not in Commercial Distribution

Package Type

Carton