OKB OTC Hearing Aid - Bluetooth Earphones 30-81-0300-0303

GUDID 00193169003507

(Authentic Accessory) Bluetooth Earphones for OKB OTC Hearing Aid GV-SA03.60

OK BIOTECH CO., LTD.

Air-conduction hearing aid, in-the-ear
Primary Device ID00193169003507
NIH Device Record Key767c484a-f04b-4e3d-8f34-d1919ac6f8c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameOKB OTC Hearing Aid - Bluetooth Earphones
Version Model NumberHT001
Catalog Number30-81-0300-0303
Company DUNS658796458
Company NameOK BIOTECH CO., LTD.
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 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

Customer Support Contacts

Phone+1 626-225-0621
Emailsupport@okbhearing.com
Phone+1 626-225-0621
Emailsupport@okbhearing.com
Phone+1 626-225-0621
Emailsupport@okbhearing.com
Phone+1 626-225-0621
Emailsupport@okbhearing.com
Phone+1 626-225-0621
Emailsupport@okbhearing.com
Phone+1 626-225-0621
Emailsupport@okbhearing.com
Phone+1 626-225-0621
Emailsupport@okbhearing.com
Phone+1 626-225-0621
Emailsupport@okbhearing.com
Phone+1 626-225-0621
Emailsupport@okbhearing.com
Phone+1 626-225-0621
Emailsupport@okbhearing.com
Phone+1 626-225-0621
Emailsupport@okbhearing.com
Phone+1 626-225-0621
Emailsupport@okbhearing.com
Phone+1 626-225-0621
Emailsupport@okbhearing.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100193169003507 [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 Date2025-07-09
Device Publish Date2025-07-01

Devices Manufactured by OK BIOTECH CO., LTD.

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00193169003507 - OKB OTC Hearing Aid - Bluetooth Earphones2025-07-09(Authentic Accessory) Bluetooth Earphones for OKB OTC Hearing Aid GV-SA03.60
00193169003507 - OKB OTC Hearing Aid - Bluetooth Earphones2025-07-09 (Authentic Accessory) Bluetooth Earphones for OKB OTC Hearing Aid GV-SA03.60
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