Andesfit Health Yes

GUDID 16953825906426

Shenzhen Urion Technology Co., Ltd

Medical device pressure monitor Medical device pressure monitor Medical device pressure monitor Medical device pressure monitor Medical device pressure monitor Medical device pressure monitor Medical device pressure monitor Medical device pressure monitor Medical device pressure monitor Medical device pressure monitor Medical device pressure monitor Medical device pressure monitor Medical device pressure monitor Medical device pressure monitor 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