Lightning X Products

GUDID 06953825904418

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06953825904418
• NIH Device Record Key: e85eee2b-adec-426b-b80a-ed1acd10f6b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lightning X Products
• Version Model Number: LXBPC-UA
• 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	06953825904418 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-28
• Device Publish Date: 2020-12-18

Devices Manufactured by Shenzhen Urion Technology Co., Ltd

• 16953825908864 - Premier HEALTH SOLUTONS: 2024-11-04
• 16953825908871 - Mitdir: 2024-11-04
• 16953825908888 - Zybs Medical: 2024-11-04
• 16953825908840 - AlphagoMed: 2024-11-01
• 16953825908857 - Andesfit Health: 2024-11-01
• 16953825908833 - N/A: 2024-10-31
• 16953825908796 - urion: 2024-10-22
• 16953825908802 - urion: 2024-10-22