Sovereign-Gear

GUDID 05060505400014

A home-use infrared forehead thermometer.

COOL APPROACH LIMITED

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.