Olive Smart Hearing Aid

GUDID 08800034600007

Olive Union inc

Air-conduction hearing aid, in-the-ear
Primary Device ID08800034600007
NIH Device Record Key8e9339ab-ca43-45ce-ac87-a22f28d5c7b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameOlive Smart Hearing Aid
Version Model NumberOLV-01
Company DUNS694767953
Company NameOlive Union inc
Device Count1
DM Exempttrue
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800034600007 [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 Number2
Public Version Date2020-10-06
Device Publish Date2018-07-02

On-Brand Devices [Olive Smart Hearing Aid]

08800034600038OLV-01W
08800034600007OLV-01

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