Disposable Caps 134203

GUDID 00834098000907

Disposable Caps Covers Probe, Box of 1000 for Exergen Temporal Scanner Thermometer

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

• Primary Device ID: 00834098000907
• NIH Device Record Key: 403225fb-df4f-439b-b04a-c4d13ed29ecf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Caps
• Version Model Number: 134203
• Catalog Number: 134203
• Company DUNS: 061266060
• Company Name: EXERGEN CORPORATION
• Device Count: 1000
• 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: true
• 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

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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 33 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 33 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 33 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 33 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 33 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 33 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 33 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 33 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 33 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 33 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 33 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 33 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 33 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 33 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 33 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 33 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00834098000907 [Unit of Use]
GS1	10834098000904 [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: 2023-06-21
• Device Publish Date: 2023-06-13

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• 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