Echo-Screen III Pro

GUDID 00382830054942

The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission or Auditory Brainstem Response screening technologies. The Echo-Screen III may be configured to support one or any combination of TEOAE, DPOAE, and AABR technologies.

NATUS MEDICAL INCORPORATED

Evoked-potential audiometer

• Primary Device ID: 00382830054942
• NIH Device Record Key: fb999ac9-7324-44bd-944f-4106fd64396e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echo-Screen III Pro
• Version Model Number: Echo-Screen III
• Company DUNS: 962519208
• Company Name: NATUS MEDICAL INCORPORATED
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-303-0306
• Email: Technical.Service@natus.com
• Phone: 1-800-303-0306
• Email: Technical.Service@natus.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 38 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830054942 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141446

FDA Product Code

• EWO: Audiometer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-25

On-Brand Devices [Echo-Screen III Pro]

• 00382830054942: The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can d
• 00382830045353: The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can d
• 00382830045339: The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can d
• 00382830045315: The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can d
• 00382830045292: The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can d
• 00382830045278: The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can d
• 00382830045247: The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can d