ALGO 3i Newborn Hearing Screener 040695, 040969

GUDID 00382830053297

The ALGO® 3i Newborn Hearing Screener is a portable, noninvasive device for screening the hearing of infants between the ages of 34 weeks corrected gestational age and six months. The screener uses Natus’ AABR® technology. Babies should be well enough for hospital discharge, and should be asleep or in a quiet state at the time of screening. The ALGO 3i screener is simple to operate and does not require special technical skills or interpretation of results. Basic training with the equipment is sufficient to learn how to screen infants correctly. A typical screening can be completed in 15 minutes or less in any clinical environment (i.e. well-baby nursery, NICU, mother’s bedside, audiology suite, outpatient clinic, or doctor’s office).

NATUS MEDICAL INCORPORATED

Evoked-potential audiometer

• Primary Device ID: 00382830053297
• NIH Device Record Key: be3253a5-b82b-4932-91b4-b514f0d54fe0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALGO 3i Newborn Hearing Screener
• Version Model Number: Algo 3i
• Catalog Number: 040695, 040969
• 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: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830053297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030823

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

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: 2017-08-28

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