Tecnimed 06700

GUDID 00182097000351

Infrared thermometer intended for intermittent measurement of human body temperature in people of all ages. Measurement site: forehead (without contact).

TECNIMED SRL

Infrared patient thermometer, skin
Primary Device ID00182097000351
NIH Device Record Key2e265ec4-b406-406e-b779-d976f4be9642
Commercial Distribution StatusIn Commercial Distribution
Brand NameTecnimed
Version Model NumberVisioFocus MINI
Catalog Number06700
Company DUNS445878788
Company NameTECNIMED SRL
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100182097000351 [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 Date2018-08-30
Device Publish Date2018-07-30

On-Brand Devices [Tecnimed]

00182097000382Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect
00182097000351Infrared thermometer intended for intermittent measurement of human body temperature in people o
00182097000511Infrared non contact thermometer intended for the intermittent measurement of human body tempera

Trademark Results [Tecnimed]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TECNIMED
TECNIMED
76165748 2751718 Live/Registered
Tecnimed srl
2000-11-15

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