Eargo SE

GUDID 00850010429533

Eargo SE System

Eargo, Inc.

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 00850010429533
• NIH Device Record Key: 5071af54-fd94-4ffc-90ad-709270828f5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eargo SE
• Version Model Number: 99-0155-001
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850010429533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221698

FDA Product Code

• 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: 2024-02-06
• Device Publish Date: 2024-01-29

On-Brand Devices [Eargo SE]

• 00850010429625: Eargo SE Large Trumpets
• 00850010429618: Eargo SE Medium Trumpets
• 00850010429601: Eargo SE Small Trumpets
• 00850010429595: Eargo SE Additional Charger
• 00850010429588: Eargo SE Additional Cable + Adaptor
• 00850010429571: Eargo SE Replacement Charger
• 00850010429564: Right Eargo SE Hearing Device
• 00850010429557: Left Eargo SE Hearing Device
• 00850010429533: Eargo SE System