ThermoWorks Wand

GUDID 10860003705305

ThermoWorks Wand Digital Forehead Thermometer

THERMOWORKS INC.

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• Primary Device ID: 10860003705305
• NIH Device Record Key: efdb05ce-ec50-4ade-8bd8-a614af5f2cfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermoWorks Wand
• Version Model Number: THD2FE
• Company DUNS: 102712080
• Company Name: THERMOWORKS INC.
• 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: 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: false

Customer Support Contacts

• Phone: 801-756-7705
• Email: tom.fisher@thermoworks.com
• Phone: 801-756-7705
• Email: tom.fisher@thermoworks.com
• Phone: 801-756-7705
• Email: tom.fisher@thermoworks.com
• Phone: 801-756-7705
• Email: tom.fisher@thermoworks.com
• Phone: 801-756-7705
• Email: tom.fisher@thermoworks.com
• Phone: 801-756-7705
• Email: tom.fisher@thermoworks.com
• Phone: 801-756-7705
• Email: tom.fisher@thermoworks.com
• Phone: 801-756-7705
• Email: tom.fisher@thermoworks.com
• Phone: 801-756-7705
• Email: tom.fisher@thermoworks.com
• Phone: 801-756-7705
• Email: tom.fisher@thermoworks.com
• Phone: 801-756-7705
• Email: tom.fisher@thermoworks.com
• Phone: 801-756-7705
• Email: tom.fisher@thermoworks.com
• Phone: 801-756-7705
• Email: tom.fisher@thermoworks.com
• Phone: 801-756-7705
• Email: tom.fisher@thermoworks.com
• Phone: 801-756-7705
• Email: tom.fisher@thermoworks.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003705308 [Primary]
GS1	10860003705305 [Package]; Contains: 00860003705308; Package: Master Pack [46 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121428

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: 2020-04-15
• Device Publish Date: 2020-04-07

Devices Manufactured by THERMOWORKS INC.

• 00860003705315 - ThermoWorks WAND Blue: 2020-07-03 Bluetooth Forehead Thermometer, infrared
• 10860003705305 - ThermoWorks Wand: 2020-04-15ThermoWorks Wand Digital Forehead Thermometer
• 10860003705305 - ThermoWorks Wand: 2020-04-15 ThermoWorks Wand Digital Forehead Thermometer