OXILINE

GUDID 06953825905354

Shenzhen Urion Technology Co., Ltd

Medical device pressure monitor

• Primary Device ID: 06953825905354
• NIH Device Record Key: 3536ba4d-3d6f-4f30-99d7-5b929633a698
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OXILINE
• 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: 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	06953825905354 [Primary]

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: 2021-10-22
• Device Publish Date: 2021-10-14

On-Brand Devices [OXILINE]

• 06953825910174: U81Q
• 06953825905354: UFR102