GAM MED

GUDID 16953825908642

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 16953825908642
• NIH Device Record Key: 6c234254-a368-491b-ac0b-4d9ed23504c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GAM MED
• Version Model Number: U81D
• 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	06953825908645 [Primary]
GS1	16953825908642 [Package]; Contains: 06953825908645; Package: Carton [28 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160019
• Premarket Notification: K243115

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: 2024-09-03
• Device Publish Date: 2024-08-26

Devices Manufactured by Shenzhen Urion Technology Co., Ltd

• 16953825909700 - WEONY: 2025-05-12
• 16953825909717 - WEONY: 2025-05-12
• 16953825909724 - Aidisy: 2025-05-12
• 16953825906631 - Invaxe: 2025-05-09
• 16953825906662 - Healthpoint: 2025-05-09
• 16953825906723 - AccuCare: 2025-05-09
• 16953825906730 - ALPHAGOMED: 2025-05-09
• 16953825909694 - AlphaMed: 2025-05-09