Tecnimed - 3J MEDICAL SUPPLIES Inc 06700

GUDID 00182097000429

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 ID: 00182097000429
• NIH Device Record Key: 65c3baff-1565-4085-98d7-ca82c87c257f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tecnimed - 3J MEDICAL SUPPLIES Inc
• Version Model Number: VisioFocus MINI
• Catalog Number: 06700
• 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: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00182097000429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160680

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-18
• Device Publish Date: 2019-09-10

On-Brand Devices [Tecnimed - 3J MEDICAL SUPPLIES Inc]

• 00182097000443: Infrared non contact thermometer intended for the intermittent measurement of human body tempera
• 00182097000436: Infrared non contact thermometer intended for the intermittent measurement of human body tempera
• 00182097000429: Infrared thermometer intended for intermittent measurement of human body temperature in people o