Hermano

GUDID B791U80EHBT0

System, measurement, blood-pressure, non-invasive

HARMONIZE INC.

Patient monitoring system module, blood pressure, noninvasive

• Primary Device ID: B791U80EHBT0
• NIH Device Record Key: 4f16ea1b-1994-44b3-9e09-44e1a5566538
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hermano
• Version Model Number: U80EH-BT
• Company DUNS: 117022733
• Company Name: HARMONIZE INC.
• 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: false
• 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
HIBCC	B791U80EHBT0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160019

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: 2019-10-22
• Device Publish Date: 2019-10-14

Devices Manufactured by HARMONIZE INC.

• B791ANJ220LB0 - Shenzhen ANJ Technology: 2019-10-22 Weight Scale
• B791U80EHBT0 - Hermano: 2019-10-22System, measurement, blood-pressure, non-invasive
• B791U80EHBT0 - Hermano: 2019-10-22 System, measurement, blood-pressure, non-invasive