ELERA Yes

GUDID 16953825905535

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 16953825905535
• NIH Device Record Key: 561f4799-e93e-47aa-8729-b684919b85ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELERA
• Version Model Number: U81E
• 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	06953825905538 [Primary]
GS1	16953825905535 [Package]; Contains: 06953825905538; Package: Carton [20 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: 2023-07-06
• Device Publish Date: 2023-06-28

On-Brand Devices [ELERA]

• 06953825902384: U60A
• 16953825905535: U81E
• 16953825908765: U82RH
• 16953825908963: U80B
• 16953825909571: U81E