SeemtraMed Infrared Ear/Forehead Thermometer

GUDID 50860001625832

Infrared ear/forehead thermometer

SEEMTRAMED LLC

Infrared patient thermometer, ear/skin
Primary Device ID50860001625832
NIH Device Record Keyac3e601c-9e7d-41d4-9523-34c508f97213
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeemtraMed Infrared Ear/Forehead Thermometer
Version Model NumberPG-IRT1603
Company DUNS117025040
Company NameSEEMTRAMED 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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone917-720-2575
Emailseemtramed@gmail.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860001625837 [Primary]
GS150860001625832 [Package]
Contains: 00860001625837
Package: Carton [60 Units]
In Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-12
Device Publish Date2019-06-10

Devices Manufactured by SEEMTRAMED LLC

00860001625806 - SeemtraMed Blood Pressure Monitor2019-11-08 Automatic electronic blood pressure monitor
50860001625832 - SeemtraMed Infrared Ear/Forehead Thermometer2019-07-12Infrared ear/forehead thermometer
50860001625832 - SeemtraMed Infrared Ear/Forehead Thermometer2019-07-12 Infrared ear/forehead thermometer
00860001625813 - SeemtraMed Infrared Thermometer2019-06-05 Infrared forehead thermometer

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