EVOLU Intelligent Blood Pressure Monitor

GUDID 04751037660045

FORANS SIA

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 04751037660045
• NIH Device Record Key: 03a42ee6-350f-4c72-9d83-2b59cfcaec09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOLU Intelligent Blood Pressure Monitor
• Version Model Number: PG-800B19L
• Company DUNS: 365515625
• Company Name: FORANS SIA
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04751037660045 [Primary]

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: 2021-06-07
• Device Publish Date: 2021-05-28

Devices Manufactured by FORANS SIA

• 04751037660038 - EVOLU Non Contact Infrared Ear/Forehead Thermometer: 2021-06-07
• 04751037660045 - EVOLU Intelligent Blood Pressure Monitor: 2021-06-07
• 04751037660045 - EVOLU Intelligent Blood Pressure Monitor: 2021-06-07