Sonohealth Yes

GUDID 16953825907409

Shenzhen Urion Technology Co., Ltd

Medical device pressure monitor

• Primary Device ID: 16953825907409
• NIH Device Record Key: 9bccbc19-eb54-4f65-8b8c-17041749ed87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonohealth
• Version Model Number: UFR102
• 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	06953825907402 [Primary]
GS1	16953825907409 [Package]; Contains: 06953825907402; 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: 2023-07-17
• Device Publish Date: 2023-07-07

Devices Manufactured by Shenzhen Urion Technology Co., Ltd

• 16953825908864 - Premier HEALTH SOLUTONS: 2024-11-04
• 16953825908871 - Mitdir: 2024-11-04
• 16953825908888 - Zybs Medical: 2024-11-04
• 16953825908840 - AlphagoMed: 2024-11-01
• 16953825908857 - Andesfit Health: 2024-11-01
• 16953825908833 - N/A: 2024-10-31
• 16953825908796 - urion: 2024-10-22
• 16953825908802 - urion: 2024-10-22