Catalog Number

-

Brand Name

ARC InstaTemp Non-Touch Infrared Thermometer

Version/Model Number

401

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

K152905

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

2e1cd61d-21b6-4b0c-b19c-303200393f8e

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

March 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-