EchoNous System

GUDID 09353278000236

General ultrasound imaging system, battery-powered

ECHONOUS, INC.

Hand-held ultrasound imaging system, body-surface

• Primary Device ID: 09353278000236
• NIH Device Record Key: 0da32c85-54d6-40d9-b70c-918472f56c03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EchoNous System
• Version Model Number: P006210
• Company DUNS: 080481089
• Company Name: ECHONOUS, 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 101.5 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	09353278000236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181574

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

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: 2020-05-14
• Device Publish Date: 2020-05-06

On-Brand Devices [EchoNous System]

• 09353278000236: General ultrasound imaging system, battery-powered
• 09353278000533: General ultrasound imaging system, battery-powered