Face Values 15-757-427

GUDID 10767056427027

HARMON 9 SECOND FLEXIBLE TIP DIGITAL THERMOMETER FAHRENHEIT

HARMON STORES, INC.

Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered

• Primary Device ID: 10767056427027
• NIH Device Record Key: 92cef185-538d-4f87-bb0c-77ee4b58a5f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Face Values
• Version Model Number: 15-757-427
• Catalog Number: 15-757-427
• Company DUNS: 804085293
• Company Name: HARMON STORES, 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00767056427020 [Primary]
GS1	10767056427027 [Package]; Contains: 30767056427021; Package: Master Carton [24 Units]; In Commercial Distribution
GS1	30767056427021 [Package]; Contains: 00767056427020; Package: Inner Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041516

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: 2016-09-12

On-Brand Devices [Face Values]

• 10767056427027: HARMON 9 SECOND FLEXIBLE TIP DIGITAL THERMOMETER FAHRENHEIT
• 30767056427014: HARMON 60 SECOND DIGITAL THERMOMETER W/BEEPER FAHRENHEIT