EarHug Pack - No Electrodes

GUDID 00817020020945

25 pair of EarHugs

INTELLIGENT HEARING SYSTEMS CORP.

Audiometric ear tip Audiometric ear tip Audiometric ear tip

• Primary Device ID: 00817020020945
• NIH Device Record Key: fc6004ab-a34f-4e49-b922-1183e6e928e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EarHug Pack - No Electrodes
• Version Model Number: M015404
• Company DUNS: 154870455
• Company Name: INTELLIGENT HEARING SYSTEMS CORP.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817020020945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073384

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: 2017-01-30

Devices Manufactured by INTELLIGENT HEARING SYSTEMS CORP.

• 00817020021126 - Aria: 2024-03-19
• 00817020021058 - Bone Vibrator w/ Cable and Headband (B81): 2021-02-18
• 00817020021065 - DD45-300 Headphones: 2021-02-18
• 00817020020808 - SmartEP Software: 2019-07-12
• 00817020020815 - SmartEP-ASSR Software: 2019-07-12
• 00817020020822 - SmartScreener-Plus2 Screener Launch: 2019-07-12
• 00817020020839 - SmartScreener-Plus2 AEP Module: 2019-07-12
• 00817020020846 - SmartScreener-Plus2 OAE Module: 2019-07-12