Tecnimed - BV Medical 0800H5

GUDID 00182097000115

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 ID: 00182097000115
• NIH Device Record Key: ceaf4322-95bd-42a3-beaf-6a3a6bba0b5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tecnimed - BV Medical
• Version Model Number: Thermofocus 0800
• Catalog Number: 0800H5
• Company DUNS: 445878788
• Company Name: TECNIMED SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00182097000078 [Primary]
GS1	00182097000115 [Package]; Contains: 00182097000078; Package: box [90 Units]; In Commercial Distribution
GS1	00182097000344 [Package]; Contains: 00182097000078; Package: box [45 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072108

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

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