ThermoWorks WAND Blue

GUDID 00860003705315

Bluetooth Forehead Thermometer, infrared

THERMOWORKS INC.

Infrared patient thermometer, skin

• Primary Device ID: 00860003705315
• NIH Device Record Key: ea837874-7ca5-42c6-a54d-cae06e8d62b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermoWorks WAND Blue
• Version Model Number: THD2FE-B
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003705315 [Primary]

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: 2020-07-03
• Device Publish Date: 2020-06-25

Devices Manufactured by THERMOWORKS INC.

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