Med One

GUDID 16953825908185

Shenzhen Urion Technology Co., Ltd

Medical device pressure monitor

• Primary Device ID: 16953825908185
• NIH Device Record Key: 03c2f016-4a68-4718-b292-d970378be45c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Med One
• Version Model Number: UFR102
• 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	06953825908188 [Primary]
GS1	16953825908185 [Package]; Contains: 06953825908188; Package: Carton [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200802

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2024-05-31
• Device Publish Date: 2024-05-23

On-Brand Devices [Med One]

• 16953825908185: UFR102
• 16953825908758: UM605