Sovereign-Gear

GUDID 05060505400014

A home-use infrared forehead thermometer.

COOL APPROACH LIMITED

Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer

• Primary Device ID: 05060505400014
• NIH Device Record Key: bbfa4284-4ae1-4691-9918-d2e980b453e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sovereign-Gear
• Version Model Number: FT-100D
• Company DUNS: 672138455
• Company Name: COOL APPROACH LIMITED
• 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: false
• 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	05060505400014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160999

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-21

On-Brand Devices [Sovereign-Gear]

• 05060505400014: A home-use infrared forehead thermometer.
• 05060505400007: A flexible tipped home-use waterproof digital thermometer.