EARGO 99-0079-001

GUDID 00850010429038

EARGO NEO Charger Replacement

Eargo, Inc.

Noninvasive device battery charger
Primary Device ID00850010429038
NIH Device Record Key1af32726-29d2-42c0-aac3-8453596920b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEARGO
Version Model Number99-0079-001
Catalog Number99-0079-001
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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(925)759-4686
Emailron.letendre@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

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850010429038 [Primary]

FDA Product Code

ESDHearing aid, air conduction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-06
Device Publish Date2019-10-14

On-Brand Devices [EARGO]

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

Trademark Results [EARGO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EARGO
EARGO
90549643 not registered Live/Pending
Eargo, Inc.
2021-02-26
EARGO
EARGO
86229148 4661088 Live/Registered
EARGO, INC.
2014-03-22
EARGO
EARGO
76328749 2738416 Dead/Cancelled
Bosch, John
2001-10-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.