Exergen Thermographic Scanner 124185

GUDID 10834098000966

DT-5000S-USB

EXERGEN CORPORATION

Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin

• Primary Device ID: 10834098000966
• NIH Device Record Key: 5a69ec91-6f81-4bec-8098-c4b82312e057
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exergen Thermographic Scanner
• Version Model Number: DT-5000S-USB
• Catalog Number: 124185
• Company DUNS: 061266060
• Company Name: EXERGEN CORPORATION
• 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: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 617-923-9900
• Email: medical@exergen.com
• Phone: 617-923-9900
• Email: medical@exergen.com
• Phone: 617-923-9900
• Email: medical@exergen.com
• Phone: 617-923-9900
• Email: medical@exergen.com
• Phone: 617-923-9900
• Email: medical@exergen.com
• Phone: 617-923-9900
• Email: medical@exergen.com
• Phone: 617-923-9900
• Email: medical@exergen.com
• Phone: 617-923-9900
• Email: medical@exergen.com
• Phone: 617-923-9900
• Email: medical@exergen.com
• Phone: 617-923-9900
• Email: medical@exergen.com
• Phone: 617-923-9900
• Email: medical@exergen.com
• Phone: 617-923-9900
• Email: medical@exergen.com
• Phone: 617-923-9900
• Email: medical@exergen.com
• Phone: 617-923-9900
• Email: medical@exergen.com
• Phone: 617-923-9900
• Email: medical@exergen.com
• Phone: 617-923-9900
• Email: medical@exergen.com
• Phone: 617-923-9900
• Email: medical@exergen.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10834098000966 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011291

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: 2024-01-10
• Device Publish Date: 2024-01-02

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• 10834098000614 - Exergen Temporal Scanner: 2023-10-19 TAT-5000S-USB-GE2, ORAL, DEG C
• 10834098000621 - Exergen Temporal Scanner: 2023-10-19 TAT-5000S-USB-GE2, ORAL, DEG F
• 10834098000850 - Exergen Temporal Scanner: 2023-10-19 TAT-5000S-US Arterial Calibration
• 10834098000867 - Exergen Temporal Scanner: 2023-10-19 TAT-5000S-US Oral Calibration
• 10834098000874 - Exergen Temporal Scanner: 2023-10-19 TAT-5000S-US Quick Release Arterial Calibration