Eargo 5

GUDID 00850010429342

Eargo 5 Charger

Eargo, Inc.

Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear
Primary Device ID00850010429342
NIH Device Record Key6ae6ec3b-c714-4c12-8421-6ec6443235e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameEargo 5
Version Model Number99-0141-001
Company DUNS079865289
Company NameEargo, Inc.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com
Phone1 (855) 690-9360
Emailinfo@eargo.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850010429342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSMHearing Aid, Air Conduction With Wireless Technology
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-08
Device Publish Date2021-09-30

On-Brand Devices [Eargo 5]

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