Wellue

GUDID 06934440100850

Shenzhen Viatom Technology Co., Ltd.

Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use

• Primary Device ID: 06934440100850
• NIH Device Record Key: 3468b863-4369-4bb9-b72d-c40ae15a2fb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wellue
• Version Model Number: BP2 Blood Pressure Monitor
• Company DUNS: 421357243
• Company Name: Shenzhen Viatom Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934440100850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193348

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: 2021-08-09
• Device Publish Date: 2021-07-30

On-Brand Devices [Wellue]

• 06934440100720: AirBP Blood Pressure Monitor
• 06934440100850: BP2 Blood Pressure Monitor