Catalog Number

-

Brand Name

SeemtraMed Infrared Ear/Forehead Thermometer

Version/Model Number

PG-IRT1603

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

K182597,K182597

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

ac3e601c-9e7d-41d4-9523-34c508f97213

Public Version Date

July 12, 2019

Public Version Number

2

DI Record Publish Date

June 10, 2019

Package DI Number

50860001625832

Quantity per Package

60

Contains DI Package

00860001625837

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton