BESTUNE

GUDID 06953825903541

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06953825903541
• NIH Device Record Key: a8771b36-858b-4e47-8827-c7c3cbdf49c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BESTUNE
• Version Model Number: U80Y
• Company DUNS: 421294358
• Company Name: Shenzhen Urion 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: true
• Serial Number: true
• Manufacturing Date: true
• 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	06953825903541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160019
• Premarket Notification: K243115

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: 2
• Public Version Date: 2022-04-25
• Device Publish Date: 2020-06-12

On-Brand Devices [BESTUNE]

• 06953825907235: U87E
• 06953825903541: U80Y