ALphagoMed

GUDID 06953825903145

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06953825903145
• NIH Device Record Key: 374a2bf7-9271-4fc6-84cb-6fdf2e47239b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALphagoMed
• Version Model Number: U80R
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06953825903145 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-04-09
• Device Publish Date: 2017-11-14

On-Brand Devices [ALphagoMed]

• 06953825904593: U81H
• 06953825903435: U80H
• 06953825903169: U60EH
• 06953825903152: U60CH
• 06953825903145: U80R
• 06953825903138: U80EH
• 06953825904883: U80E
• 06953825909024: U807
• 06953825903671: U80K
• 06953825903756: U82H
• 06953825903978: U80U
• 06953825904067: U80RH
• 06953825909055: U81NH
• 06953825909369: U80M
• 06953825907310: U60BH
• 06953825905323: U80M
• 06953825905859: U80T
• 16953825908840: U80EH
• 16953825909632: UFR102
• 16953825909625: U80EH
• 16953825909618: U80EH
• 16953825909649: U83Z
• 16953825906730: U87E