Salux™ SALUX-AU-01

GUDID 00860007826603

Bluetooth audiometer portion of Salux™ Tablet-Controlled Audiometer. The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI Standard 3.6. The Salux™ Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux™ Audiometer solution can be used to display video or static content to the participant.

Examinetics, Inc.

Tone audiometer, semi-automated

• Primary Device ID: 00860007826603
• NIH Device Record Key: 32f7093c-803d-4558-8880-12e79f061c78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Salux™
• Version Model Number: SALUX-AU-01
• Catalog Number: SALUX-AU-01
• Company DUNS: 147251958
• Company Name: Examinetics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: 9137482000
• Email: clientengagement@examinetics.com
• Phone: 9137482000
• Email: clientengagement@examinetics.com
• Phone: 9137482000
• Email: clientengagement@examinetics.com
• Phone: 9137482000
• Email: clientengagement@examinetics.com
• Phone: 9137482000
• Email: clientengagement@examinetics.com
• Phone: 9137482000
• Email: clientengagement@examinetics.com
• Phone: 9137482000
• Email: clientengagement@examinetics.com
• Phone: 9137482000
• Email: clientengagement@examinetics.com
• Phone: 9137482000
• Email: clientengagement@examinetics.com
• Phone: 9137482000
• Email: clientengagement@examinetics.com
• Phone: 9137482000
• Email: clientengagement@examinetics.com
• Phone: 9137482000
• Email: clientengagement@examinetics.com
• Phone: 9137482000
• Email: clientengagement@examinetics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007826603 [Primary]

FDA Product Code

• EWO: Audiometer

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: 2022-02-04
• Device Publish Date: 2022-01-27

On-Brand Devices [Salux™]

• 00860007826627: iOS application portion for Salux™ Tablet-Controlled Audiometer system. The Examinetics Tablet
• 00860007826610: Headphone portion for Salux™ Tablet-Controlled Audiometer. The Examinetics Tablet-Controlled
• 00860007826603: Bluetooth audiometer portion of Salux™ Tablet-Controlled Audiometer. The Examinetics Tablet-C
• 00860007826641: iOS application portion for Salux™ Tablet-Controlled Audiometer system. The Examinetics Tablet
• 00860007826634: Bluetooth audiometer portion of Salux™ Tablet-Controlled Audiometer. The Examinetics Tablet-C