AUPO

GUDID 16955647600070

Infrared Thermometer

FUDAKANG INDUSTRIAL CO., LTD.

Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear

• Primary Device ID: 16955647600070
• NIH Device Record Key: d6dab353-301f-4eee-9d7b-1c518c674271
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUPO
• Version Model Number: FT-F21
• Company DUNS: 544522665
• Company Name: FUDAKANG INDUSTRIAL CO., LTD.
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	06955647600073 [Primary]
GS1	16955647600070 [Package]; Contains: 06955647600073; Package: Inner Box [16 Units]; In Commercial Distribution
GS1	26955647600077 [Package]; Contains: 06955647600073; Package: Case [128 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111703

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: 2020-12-01
• Device Publish Date: 2020-11-23

On-Brand Devices [AUPO]

• 16955647600087: Blood Pressure Monitor
• 16955647600070: Infrared Thermometer