ProCare IR Thermometer

GUDID 00372217003014

ProCare IR Thermometer - EFT 161

ARISE MEDICAL LLC

Infrared patient thermometer, ear
Primary Device ID00372217003014
NIH Device Record Key663fe8bd-2943-4331-a290-85361804b80b
Commercial Distribution StatusIn Commercial Distribution
Brand NameProCare IR Thermometer
Version Model Number240390
Company DUNS081149273
Company NameARISE MEDICAL LLC
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 Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100372217003014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-01
Device Publish Date2018-10-01

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