Exergen Thermographic Scanner 124185

GUDID 10834098000966

DT-5000S-USB

EXERGEN CORPORATION

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

Devices Manufactured by EXERGEN CORPORATION

• 10834098000966 - Exergen Thermographic Scanner: 2024-01-10DT-5000S-USB
• 10834098000966 - Exergen Thermographic Scanner: 2024-01-10 DT-5000S-USB
• 10834098000973 - Exergen Temporal Scanner: 2023-10-26 Special Price Pediatric Promo Kit
• 10834098000607 - Exergen Temporal Scanner: 2023-10-19 TAT-5000S-USB-GE2, ART, DEG F
• 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