Rexall

GUDID 06931562701323

intended to measure human body temperature on forehead

HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.

Infrared patient thermometer, skin

• Primary Device ID: 06931562701323
• NIH Device Record Key: b4ca119a-b3de-4159-be70-0dd0f5ea8a9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rexall
• Version Model Number: FT-100B
• Company DUNS: 544611767
• Company Name: HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS 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: false
• 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	06931562701323 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-27
• Device Publish Date: 2022-06-17