Eargo 5

GUDID 00850010429199

EARGO 5 System

Eargo, Inc.

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 00850010429199
• NIH Device Record Key: cb39b02f-7d63-4288-9350-f3aff7a1ab37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eargo 5
• Version Model Number: 99-0114-001
• Company DUNS: 079865289
• Company Name: Eargo, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com
• Phone: 1 (855) 690-9360
• Email: info@eargo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850010429199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221698

FDA Product Code

• OSM: Hearing Aid, Air Conduction With Wireless Technology
• QUH: Self-Fitting Air-Conduction Hearing Aid, Over The Counter

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: 2021-10-08
• Device Publish Date: 2021-09-30

On-Brand Devices [Eargo 5]

• 00850010429342: Eargo 5 Charger
• 00850010429335: Large Closed Petals
• 00850010429311: Medium Closed Petals
• 00850010429298: Large Open Petals
• 00850010429281: Medium Open Petals
• 00850010429267: Eargo 5 Microphone Caps
• 00850010429250: Eargo 5 Power Cord and Adapter
• 00850010429243: Eargo 5 Replacement Charger
• 00850010429236: Right Eargo 5 Hearing Device
• 00850010429229: Left Eargo 5 Hearing Device
• 00850010429212: Eargo 5 Sample Kit
• 00850010429199: EARGO 5 System