Hearing Aid Feature (HAF)

GUDID 00195949149924

Hearing Aid Feature iOS (1.X)

APPLE INC.

Air-conduction hearing aid, in-the-ear
Primary Device ID00195949149924
NIH Device Record Key8445d022-bdc7-4360-a52e-f916dd18072c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHearing Aid Feature (HAF)
Version Model NumberFeature version 1.X
Company DUNS060704780
Company NameAPPLE INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100195949149924 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

SCRAir-Conduction Hearing Aid Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-29
Device Publish Date2024-10-21

On-Brand Devices [Hearing Aid Feature (HAF)]

00195950095074Hearing Aid Feature watchOS (1.X)
00195950095067Hearing Aid Feature macOS (1.X)
00195949149931Hearing Aid Feature AirPods Pro 2 Firmware (1.X)
00195949149924Hearing Aid Feature iOS (1.X)

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