Catalog Number

JXB-178

Brand Name

MedSource, Non-Contact Infrared Thermometer

Version/Model Number

MS-131001

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)

-

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

1762a44c-48c3-4cc6-8ccd-0e2510f2c8df

Public Version Date

December 16, 2020

Public Version Number

1

DI Record Publish Date

December 08, 2020

Package DI Number

00816703029916

Quantity per Package

40

Contains DI Package

00816703029909

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case