Olive Air OTC

GUDID 08809637100426

Olive Union inc

Air-conduction hearing aid, in-the-ear
Primary Device ID08809637100426
NIH Device Record Keyb4f9fde3-d043-4a76-9f9b-d5c5944aa1e9
Commercial Distribution Discontinuation2026-12-31
Commercial Distribution StatusIn Commercial Distribution
Brand NameOlive Air OTC
Version Model NumberOU0P030203
Company DUNS694767953
Company NameOlive Union inc
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS108809637100426 [Primary]

FDA Product Code

QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-07
Device Publish Date2024-07-30

On-Brand Devices [Olive Air OTC]

08809637100426OU0P030203
08809637100419OU0P030303

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.