Etymotic Research

GUDID 00846430004917

DPOAE Probe System

ETYMOTIC RESEARCH, INC.

Otoacoustic emission system, battery-powered

• Primary Device ID: 00846430004917
• NIH Device Record Key: 0eeb3a51-d2f4-4f69-a6ef-cd57bae92e4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Etymotic Research
• Version Model Number: ER10C System
• Company DUNS: 115380859
• Company Name: ETYMOTIC RESEARCH, 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846430004917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930553

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: 2016-09-20

On-Brand Devices [Etymotic Research]

• 00846430005372: Electrode Eartip cables 2/pkg
• 00846430004955: ER7C series B Microphone ER7C series B Pre-Amp ER7-14 Probe Tubes
• 00846430004948: ER7C series B Pre-Amplifier
• 00846430004931: ER7 Series B Probe Microphone
• 00846430004924: 10C amplifier
• 00846430004917: DPOAE Probe System
• 00846430004900: 10B+ Amplifier
• 00846430004894: ER 10B+ Low Noise Microphone, Single Use Ear tips, 10B+ Pre-amplifier, Probe Tubes, Foam Ear tip
• 00846430004818: Gold plated brass tube nipples
• 00846430004597: ER1-14A foam ear tips with ER7-14C probe tubes
• 00846430004061: Gold Electrode Eartips 10mm 20/pkg
• 00846430004047: Gold Electrode Eartips 13mm 20/pk
• 00846430005297: ER10D Probe system for use with audio-metric equipment
• 00846430005419: Clear ER-3 Tubes - 6pack
• 00846430005402: Blue and Red ER-3 Tubes
• 00846430005334: cable replacement for ER3C - 7 ft.
• 00846430005426: Replacement ER-3C (300) Cable for Natus ER-3