Andesfit Health Yes

GUDID 16953825906426

Shenzhen Urion Technology Co., Ltd

Medical device pressure monitor

• Primary Device ID: 16953825906426
• NIH Device Record Key: 2c4ba48d-ea92-4d97-b012-21c912a18cab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Andesfit Health
• Version Model Number: UFR103
• 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	06953825906429 [Primary]
GS1	16953825906426 [Package]; Contains: 06953825906429; Package: Carton [40 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: 2022-09-19
• Device Publish Date: 2022-09-09

On-Brand Devices [Andesfit Health]

• 06953825903640: U80L
• 06953825905439: U86E
• 06953825905934: U62I
• 16953825906426: UFR103
• 16953825908857: U80BH