EARGO 99-0062-001

GUDID 00850010429090

EARGO Replacement Flexi Dome, Size Large

Eargo, Inc.

Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard Hearing aid wax guard

• Primary Device ID: 00850010429090
• NIH Device Record Key: f282c1e6-4c3d-48b0-b330-14616bb1237e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EARGO
• Version Model Number: 99-0062-001
• Catalog Number: 99-0062-001
• Company DUNS: 079865289
• Company Name: Eargo, Inc.
• Device Count: 6
• 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: true
• Serial Number: false
• 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: false

Customer Support Contacts

• Phone: +1(925)759-4686
• Email: ron.letendre@eargo.com
• Phone: +1(925)759-4686
• Email: ron.letendre@eargo.com
• Phone: +1(925)759-4686
• Email: ron.letendre@eargo.com
• Phone: +1(925)759-4686
• Email: ron.letendre@eargo.com
• Phone: +1(925)759-4686
• Email: ron.letendre@eargo.com
• Phone: +1(925)759-4686
• Email: ron.letendre@eargo.com
• Phone: +1(925)759-4686
• Email: ron.letendre@eargo.com
• Phone: +1(925)759-4686
• Email: ron.letendre@eargo.com
• Phone: +1(925)759-4686
• Email: ron.letendre@eargo.com
• Phone: +1(925)759-4686
• Email: ron.letendre@eargo.com
• Phone: +1(925)759-4686
• Email: ron.letendre@eargo.com
• Phone: +1(925)759-4686
• Email: ron.letendre@eargo.com
• Phone: +1(925)759-4686
• Email: ron.letendre@eargo.com
• Phone: +1(925)759-4686
• Email: ron.letendre@eargo.com
• Phone: +1(925)759-4686
• Email: ron.letendre@eargo.com
• Phone: +1(925)759-4686
• Email: ron.letendre@eargo.com
• Phone: +1(925)759-4686
• Email: ron.letendre@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	00850010429090 [Primary]
GS1	10850010429097 [Unit of Use]

FDA Product Code

• ESD: Hearing aid, air conduction

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: 2019-10-22
• Device Publish Date: 2019-10-14

On-Brand Devices [EARGO]

• 00850010429120: EARGO Replacement Flexi Palm, Size Large
• 00850010429113: EARGO Replacement Flexi Palm, Size Regular
• 00850010429106: EARGO Replacement Flexi Fiber, Size Large
• 00850010429090: EARGO Replacement Flexi Dome, Size Large
• 00850010429083: EARGO Replacement Flexi Fiber, Size Regular
• 00850010429069: EARGO Replacement Flexi Dome, Size Regular
• 00850010429052: EARGO NEO, Replacement Hearing Device, Left
• 00850010429045: EARGO NEO, Replacement Hearing Device, Right
• 00850010429038: EARGO NEO Charger Replacement
• 00850010429021: EARGO NEO System
• 00850010429175: EARGO NEO HiFi, Accessory Kit, Tetra Flexi Palm, Size Large
• 00850010429168: EARGO NEO HiFi, Accessory Kit, Tetra Flexi Palm, Size Regular
• 00850010429151: EARGO NEO HiFi, Replacement Hearing Device, Left
• 00850010429144: EARGO NEO HiFi, Replacement Hearing Device, Right
• 00850010429137: EARGO NEO HiFi System
• 00850010429076: EARGO NEO HiFi Charger Replacement
• 10850010429189: EARGO NEO ACCESSORY KIT, FLEXI PALM, SIZE SMALL
• 00850010429441: Eargo 5, 6 & 7 Charger, Power Cord & Adaptor