ARC InstaTemp Non-Touch Infrared Thermometer

GUDID 05391525574011

The ARC InstaTemp MD Digital Non-Touch Infrared Thermometer is intended to be used in the clinical setting to measure temperature in infants and adults.

ARC DEVICES USA INC

Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin
Primary Device ID05391525574011
NIH Device Record Key2e1cd61d-21b6-4b0c-b19c-303200393f8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameARC InstaTemp Non-Touch Infrared Thermometer
Version Model Number401
Company DUNS079758824
Company NameARC DEVICES USA INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS105391525574011 [Primary]
GS105391525574011 [Primary]
GS105391525574011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-05-21
Device Publish Date2017-03-31

On-Brand Devices [ARC InstaTemp Non-Touch Infrared Thermometer]

05391525574014The ARC InstaTemp MD Digital Non-Touch Infrared Thermometer is intended to be used in the clinic
05391525574011The ARC InstaTemp MD Digital Non-Touch Infrared Thermometer is intended to be used in the clinic

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