Earscan 3 05.001

GUDID 00862185000325

Earscan 3 Automatic Threshold Audiometer.

MICRO AUDIOMETRICS CORPORATION

Tone audiometer, automated

• Primary Device ID: 00862185000325
• NIH Device Record Key: f1c25859-8247-476b-a23b-bce89900d889
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Earscan 3
• Version Model Number: ES3
• Catalog Number: 05.001
• Company DUNS: 048573265
• Company Name: MICRO AUDIOMETRICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: false

Customer Support Contacts

• Phone: 866-327-7226
• Email: support@microaud.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862185000325 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-08

On-Brand Devices [Earscan 3]

• 00862185000325: Earscan 3 Automatic Threshold Audiometer.
• 00862185000318: Earscan 3 Screening Audiometer.
• 00862185000301: Earscan 3 Manual Audiometer.