Eargo RX

GUDID 00850010429205

Eargo 7-Rx New System

Eargo, Inc.

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 00850010429205
• NIH Device Record Key: 9f42934e-9e06-4c02-bf8d-4b1c9e2549af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eargo RX
• Version Model Number: 99-0177-001
• Company DUNS: 079865289
• Company Name: Eargo, Inc.
• Device Count: 1
• DM Exempt: true
• 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: 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
• 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	00850010429205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221698

FDA Product Code

• QDD: Self-Fitting Air-Conduction Hearing Aid, Prescription

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: 2024-06-25
• Device Publish Date: 2024-06-17

On-Brand Devices [Eargo RX]

• 00850010429274: Eargo SE-Rx New System
• 00850010429205: Eargo 7-Rx New System