Tecnimed - BV Medical 0700A2

GUDID 00182097000054

Infrared non contact thermometer intended for the intermittent measurement of human body temperature in people of all ages

TECNIMED SRL

Infrared patient thermometer, skin
Primary Device ID00182097000054
NIH Device Record Key6b6b0ce8-6e84-4854-96f5-b94f111425cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameTecnimed - BV Medical
Version Model NumberThermofocus 0700
Catalog Number0700A2
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 Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100182097000054 [Primary]
GS100182097000085 [Package]
Package: box [150 Units]
In Commercial Distribution
GS100182097000092 [Package]
Package: box [50 Units]
In Commercial Distribution
GS100182097000375 [Package]
Package: box [80 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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-12

On-Brand Devices [Tecnimed - BV Medical]

00182097000184Infrared non contact thermometer intended for the intermittent measurement of human body tempera
00182097000115Infrared non contact thermometer intended for the intermittent measurement of human body tempera
00182097000061Infrared non contact thermometer intended for the intermittent measurement of human body tempera
00182097000054Infrared non contact thermometer intended for the intermittent measurement of human body tempera
00182097000474Infrared non contact thermometer intended for the intermittent measurement of human body tempera

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