Exergen DermaTemp 104910

GUDID 10834098000355

Dermatemp 1001 LN

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

• Primary Device ID: 10834098000355
• NIH Device Record Key: 65a38472-5f4b-491d-a373-8d7832ce9e92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exergen DermaTemp
• Version Model Number: Dermatemp 1001
• Catalog Number: 104910
• 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: 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	10834098000355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K873010

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: 2016-09-24

On-Brand Devices [Exergen DermaTemp]

• 10834098000522: DT-2000 Bluetooth
• 10834098000508: DT-RS232, Dermatemp RS-232
• 10834098000379: DermaTemp 1001 R/S
• 10834098000355: Dermatemp 1001 LN