Catalog Number

-

Brand Name

Bose Hear App

Version/Model Number

865924-0010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 17, 2022

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

QDD

Product Code Name

Self-Fitting Air-Conduction Hearing Aid

Public Device Record Key

de97be33-a9e0-4096-8a0d-7e05d193fc28

Public Version Date

October 18, 2022

Public Version Number

2

DI Record Publish Date

May 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-