Catalog Number

Not Applicable

Brand Name

MedSource Infrared, Non-Contact Thermometer

Version/Model Number

MS-131000-RCS

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K090361,K090361

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

041d8728-2184-4f42-8d49-10062d04a60c

Public Version Date

May 10, 2021

Public Version Number

1

DI Record Publish Date

April 30, 2021

Package DI Number

00816703024751

Quantity per Package

40

Contains DI Package

00816703024744

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case