Wellue /

GUDID 16927709402441

Blood Pressure Monitor

Shenzhen Jamr Medical Technology Co., Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 16927709402441
• NIH Device Record Key: 2f7eb411-10d0-4ce1-9a7b-4185abcb166c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wellue
• Version Model Number: B02S
• Catalog Number: /
• Company DUNS: 421350239
• Company Name: Shenzhen Jamr Medical 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06927709402444 [Primary]
GS1	16927709402441 [Package]; Contains: 06927709402444; Package: Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200437

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: 2022-01-07
• Device Publish Date: 2021-12-30

On-Brand Devices [Wellue]

• 16927709402397: B02T
• 16927709402380: B02
• 16927709402441: Blood Pressure Monitor