Exergen Light Touch 133830F

GUDID 10834098000409

LTX-1 Oral Calibration Fahrenheit

EXERGEN CORPORATION

Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear

• Primary Device ID: 10834098000409
• NIH Device Record Key: 6af0a8e9-290a-46f5-8457-8136d518cac5
• Commercial Distribution Discontinuation: 2021-04-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Exergen Light Touch
• Version Model Number: LTX-1
• Catalog Number: 133830F
• 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: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10834098000409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K882949

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: 2021-12-22
• Device Publish Date: 2016-09-24

On-Brand Devices [Exergen Light Touch]

• 10834098000416: LTX-1 Oral Calibration Celcius
• 10834098000430: LXN-1
• 10834098000423: LXTA
• 10834098000409: LTX-1 Oral Calibration Fahrenheit
• 10834098000393: LTX-1 Calibration Celcius
• 10834098000386: LTX-1 Calibration Degree Fahrenheit