Firhealth

GUDID 06943893999102

Shenzhen Aoeom Cloud Health Technology Co., Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06943893999102
• NIH Device Record Key: be5b2f96-422e-4e32-bd3a-8d9192818dfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Firhealth
• Version Model Number: BP367A
• 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: 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	06943893999102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172896

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2019-11-08
• Device Publish Date: 2018-04-18

On-Brand Devices [Firhealth]

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