N/A Yes

GUDID 16953825907553

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 16953825907553
• NIH Device Record Key: c90f8aea-5238-4bc4-acaa-98abf6ae103a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: U80A
• 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	06953825907556 [Primary]
GS1	16953825907553 [Package]; Contains: 06953825907556; Package: Carton [24 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: 2023-09-25
• Device Publish Date: 2023-09-16

On-Brand Devices [N/A]

• 06953825905729: U81V
• 06953825905958: U82E
• 06953825905941: U81E
• 16953825906341: U82NH
• 16953825906402: U82V
• 16953825906525: U85W
• 16953825906594: U80W
• 16953825906617: U80EH
• 16953825906945: N/A
• 16953825906921: N/A
• 16953825907096: U81CH
• 16953825907089: U82V
• 16953825907195: U81U
• 16953825907201: 81V
• 16953825907423: U80N
• 16953825907553: U80A
• 16953825907706: U82V
• 16953825908116: N/A