ER-2

GUDID 00846430005037

ER-2 Insert Earphone (pair), ER1-21, ER1-14A, ER1-14B-S

ETYMOTIC RESEARCH, INC.

Auditory stimulator

• Primary Device ID: 00846430005037
• NIH Device Record Key: 9f0406b1-18b1-4d5c-8da5-0eb6cb4f65df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ER-2
• Version Model Number: ER-2 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: true
• Serial Number: false
• 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	00846430005037 [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: 2016-09-19

On-Brand Devices [ER-2]

• 00846430005037: ER-2 Insert Earphone (pair), ER1-21, ER1-14A, ER1-14B-S
• 00846430004979: Insert Earphone for Research