BP Wizard

GUDID 06943893999140

Shenzhen Aoeom Cloud Health Technology Co., Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06943893999140
• NIH Device Record Key: aca27dad-7a0a-4e7e-9846-9a1e4c4e4541
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BP Wizard
• Version Model Number: U80R
• 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	06943893999140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160019

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: 2018-05-09

Devices Manufactured by Shenzhen Aoeom Cloud Health Technology Co., Ltd.

• 06943893902034 - Firhealth: 2019-11-08
• 06943893999102 - Firhealth: 2019-11-08
• 06943893999140 - BP Wizard: 2019-11-08
• 06943893999140 - BP Wizard: 2019-11-08
• 06943893999157 - Medokare: 2019-11-08
• 06943893999195 - B.WEISS Personal Care: 2018-09-03
• 06943893902003 - Firhealth: 2018-07-06
• 06943893902010 - Mospro: 2018-07-06
• 06943893920311 - Firhealth: 2018-07-06