Boncare

GUDID 00860011164920

Hangzhou Universal Electronic Co.,Ltd.

Infrared patient thermometer, skin

• Primary Device ID: 00860011164920
• NIH Device Record Key: f1f30eb1-e027-4272-99a7-72fd7304c733
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Boncare
• Version Model Number: FT-100A
• Company DUNS: 679945639
• Company Name: Hangzhou Universal Electronic 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011164920 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160802

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: 2025-04-04
• Device Publish Date: 2025-03-27

On-Brand Devices [Boncare]

• 06949395046009: FT-100A
• 00860011164920: FT-100A
• 00860011164913: FT-100A