Miracle-Ear App

GUDID 00860001471700

App IOS 2.0.1. This database entry also covers the following minor software updates: v2.0.2: (01)00860001471700(11)190807(10)202; v2.0.3: (01)00860001471700(11)190927(10)203; v2.0.4: (01)00860001471700(11)191014(10)204; v2.0.5: (01)00860001471700(11)191218(10)205; v2.0.6:(01)00860001471700(11)200227(10)206

AMPLIFON SPA

Hearing device remote control
Primary Device ID00860001471700
NIH Device Record Key46f06715-1e02-4e4b-8edf-cb296c38e151
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiracle-Ear App
Version Model Number2.0.1
Company DUNS428013775
Company NameAMPLIFON SPA
Device Count1
DM Exemptfalse
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 Numberfalse
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(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com
Phone(866) 396-3749
Emailapp@miracle-ear.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860001471700 [Primary]

FDA Product Code

OSMHearing Aid, Air Conduction With Wireless Technology

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number8
Public Version Date2020-02-28
Device Publish Date2019-07-02

On-Brand Devices [Miracle-Ear App]

00860001471717App Android 2.0.1. This database entry also covers the following minor software updates: v2.0.2
00860001471700App IOS 2.0.1. This database entry also covers the following minor software updates: v2.0.2: (01
08059606110356Hearing device app
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