ThermoWorks WAND Clinical

GUDID 00860003705339

ThermoWorks Forehead Thermometer, WAND Clinical

THERMOWORKS INC.

Infrared patient thermometer, skin

• Primary Device ID: 00860003705339
• NIH Device Record Key: f0f409f6-9b74-40f1-9f1f-b35e3bf5bdaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermoWorks WAND Clinical
• Version Model Number: TX-5710
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003705339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240648

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: 2024-09-02
• Device Publish Date: 2024-08-23

Devices Manufactured by THERMOWORKS INC.

• 00860003705322 - ThermoWorks WAND Mini: 2024-09-02 ThermoWorks Forehead Thermometer, WAND Mini
• 00860003705339 - ThermoWorks WAND Clinical: 2024-09-02ThermoWorks Forehead Thermometer, WAND Clinical
• 00860003705339 - ThermoWorks WAND Clinical: 2024-09-02 ThermoWorks Forehead Thermometer, WAND Clinical
• 00860003705315 - ThermoWorks WAND Blue: 2020-07-03 Bluetooth Forehead Thermometer, infrared
• 10860003705305 - ThermoWorks Wand: 2020-04-15 ThermoWorks Wand Digital Forehead Thermometer