FDA UDI Not in Commercial Distribution 🇺🇸 United States

Bose Hear App

DI: 00017817831918 · Model: 865924-0010 · BOSE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Bose Hear App
Primary DI
00017817831918
Version / Model
865924-0010
Company Name
BOSE CORPORATION
Labeler DUNS
002579431
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-05-18
Public Version
2
Public Version Date
2022-10-18
Public Version Status
Update
Public Device Record Key
de97be33-a9e0-4096-8a0d-7e05d193fc28
Distribution End Date
2022-10-17

Device Description

A mobile companion app for Bose® Hear products

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
QDD Self-Fitting Air-Conduction Hearing Aid

GMDN Terms

Code Name
47169 Air-conduction hearing aid, receiver-in-canal

Identifiers

Type ID
Primary 00017817831918

Customer Contacts