B WELL

GUDID 16947468500202

Blood pressure monitor

Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 16947468500202
• NIH Device Record Key: cab40420-9a2c-404f-af7c-9e0682818142
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B WELL
• Version Model Number: ePA-09B4
• Company DUNS: 529903321
• Company Name: Shenzhen Belter Health Measurement and Analysis 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06947468556455 [Primary]
GS1	16947468500202 [Package]; Contains: 06947468556455; Package: BOX [1 Units]; In Commercial Distribution
GS1	26947468500216 [Package]; Package: BOX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K134029

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: 2021-08-19
• Device Publish Date: 2021-08-11

On-Brand Devices [B WELL]

• 16947468500202: Blood pressure monitor
• 16947468500196: Body temperature
• 16947468500219: Wall Mt Forehead Thermometer