KARDIGI

GUDID 16953825908666

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 16953825908666
• NIH Device Record Key: 7165be1e-f636-4081-9d97-a63197b73a78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KARDIGI
• Version Model Number: U82RH
• 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	06953825908669 [Primary]
GS1	16953825908666 [Package]; Contains: 06953825908669; Package: Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160019

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: 2024-09-09
• Device Publish Date: 2024-08-31

Devices Manufactured by Shenzhen Urion Technology Co., Ltd

• 16953825908734 - N/A: 2024-09-19 n/A
• 16953825908659 - N/A: 2024-09-11 N/A
• 16953825908697 - N/A: 2024-09-11 N/A
• 16953825908666 - KARDIGI: 2024-09-09
• 16953825908666 - KARDIGI: 2024-09-09
• 16953825908673 - ALPHAMED: 2024-09-09
• 16953825908642 - GAM MED: 2024-09-03
• 16953825908543 - ALPHAMED: 2024-08-19
• 16953825908475 - FOCUSED ADULT ADHD CLINIC: 2024-08-09