wellue

GUDID 16927709402380

Shenzhen Jamr Medical Technology Co., Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 16927709402380
• NIH Device Record Key: bc361344-dfa8-41ef-a894-22dea7017dbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: wellue
• Version Model Number: B02
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06927709402383 [Primary]
GS1	16927709402380 [Package]; Contains: 06927709402383; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172171

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: 2020-10-20
• Device Publish Date: 2020-10-12

On-Brand Devices [wellue]

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