MD HEALTH USA

GUDID 06953825904562

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06953825904562
• NIH Device Record Key: 8ce66ab0-a4a4-415a-9d11-478de49b0bcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MD HEALTH USA
• Version Model Number: U80R
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06953825904562 [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: 2020-04-09
• Device Publish Date: 2018-11-05

On-Brand Devices [MD HEALTH USA]

• 06953825904579: U60CH
• 06953825904562: U80R