urion Yes

GUDID 16953825908802

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 16953825908802
• NIH Device Record Key: 0dbc1340-4e14-4a5f-a2a0-8ca45e3cd28d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: urion
• Version Model Number: U82V
• Catalog Number: Yes
• 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: false
• 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	06953825908805 [Primary]
GS1	16953825908802 [Package]; Contains: 06953825908805; Package: Carton [40 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-22
• Device Publish Date: 2024-10-14

On-Brand Devices [urion]

• 06953825902957: U80NH
• 06953825902711: U60BH
• 06953825902704: U80EH
• 06953825902698: U80K
• 06953825901929: U80AH
• 06953825901912: U80A
• 06953825901905: U60A
• 06953825901707: U80BH
• 06953825901691: U80B
• 06953825901653: U60AH
• 06953825904050: U80EH
• 06953825904401: U62GH
• 06953825904357: U81RH
• 06953825904340: U83H
• 16953825908819: UFR201
• 16953825908802: U82V
• 16953825908796: U60CH