Andesfit Health Yes

GUDID 06953825905934

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06953825905934
• NIH Device Record Key: b6b64e53-e0d8-4c06-a934-55f81cbbb306
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Andesfit Health
• Version Model Number: U62I
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06953825905934 [Primary]
GS1	16953825905931 [Package]; Package: Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141683

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2022-06-13
• Device Publish Date: 2022-06-03

On-Brand Devices [Andesfit Health]

• 06953825903640: U80L
• 06953825905439: U86E
• 06953825905934: U62I
• 16953825906426: UFR103
• 16953825908857: U80BH
• 16953825909076: U60AH