Firhealth

GUDID 06943893920311

Shenzhen Aoeom Cloud Health Technology Co., Ltd.

Infrared patient thermometer, skin

• Primary Device ID: 06943893920311
• NIH Device Record Key: d73d6fce-a4cf-499b-83a7-09ad99ddd7fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Firhealth
• Version Model Number: AT-FR401
• Company DUNS: 544473571
• Company Name: Shenzhen Aoeom Cloud Health Technology 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: true
• 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	06943893920311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131243

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: 2017-03-20

On-Brand Devices [Firhealth]

• 06943893999102: BP367A
• 06943893920311: AT-FR401
• 06943893902041: AT-S4320
• 06943893902034: U80EH
• 06943893902003: AT-FR200