Exergen Temporal Scanner 124231-AF-GN

GUDID 10834098000485

TAT5000S-USB Arterial Calibration Generic

EXERGEN CORPORATION

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• Primary Device ID: 10834098000485
• NIH Device Record Key: c9a83800-3060-43b2-869e-d15294f68b2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exergen Temporal Scanner
• Version Model Number: TAT5000S-USB
• Catalog Number: 124231-AF-GN
• 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
• 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

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10834098000485 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-12-04
• Device Publish Date: 2017-04-11

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• 10834098000300: TAT5000S-CORO Oral Calibration - Fahrenheit
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• 10834098000270: TAT5000S Midmark
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• 10834098000249: TAT5000S-USB Oral Calibration - Fahrenheit
• 10834098000232: TAT5000S-USB Arterial Calibration - Celcius
• 10834098000225: TAT5000S-USB Arterial Calibration - Fahrenheit
• 10834098000218: TAT5000S-TTL Oral Calibration - Celcius
• 10834098000201: TAT5000S-TTL Arterial Calibration - Celcius
• 10834098000195: TAT5000S-TTL Oral Calibration - Fahrenheit
• 10834098000188: TAT5000S-TTL Arterial Calibration - Fahrenheit
• 10834098000171: TAT5000 Dual Security 20 Oral Calibration
• 10834098000164: TAT5000 Dual Security 20 Arterial Calibration
• 10834098000157: TAT5000 Dual Security 5 Oral Calibration
• 10834098000140: TAT5000 Dual Security 5 Arterial Calibratiom
• 10834098000133: TAT5000 Quick Release Oral Calibration
• 10834098000126: TAT5000 Quick Release Arterial Calibration
• 10834098000102: TAT5000 Oral Calibration
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• 10834098000539: 124229-AF-EP
• 10834098000591: TAT-5000S-USB-GE2, ART, DEG F
• 00834098003021: TAT-2000C Temporal Scanner w/Safetyscan Caps
• 10834098000577: TAT-5000S-RS232-MUSB Oral Calibration - Celcius
• 10834098000560: TAT-5000S-RS232-MUSB Arterial Calibration - Celcius
• 10834098000553: TAT-5000S-RS232-MUSB Oral Calibration - Fahrenheit
• 10834098000546: TAT-5000S-RS232-MUSB Arterial Calibration - Fahrenheit
• 10834098000881: TAT-5000S-US Quick Release Oral Calibration
• 10834098000874: TAT-5000S-US Quick Release Arterial Calibration
• 10834098000867: TAT-5000S-US Oral Calibration
• 10834098000850: TAT-5000S-US Arterial Calibration
• 10834098000621: TAT-5000S-USB-GE2, ORAL, DEG F
• 10834098000614: TAT-5000S-USB-GE2, ORAL, DEG C
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