FDA.reportPublic FDA data

WUSH

Primary DI
06936189900746
Brand
WUSH
Company
GUANGDONG OKAY TECHNOLOGY CO.,LTD.
Model
WUSH0106,WUSH0706,WUSH0906,WUSH0103,WUSH1012
Device description
Wush Powered Ear Cleaner,Black wolf-Wush Rechargeable (Basic, 6 tip, catch cup)This device complies with part 18 of FCC rules.
Published
2023-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRDApplicator, Ent Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRDApplicator, Ent DrugEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936189900746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936189900746069361899007466936189900746

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal lavage systemA device assembly designed for automated or semi-automated irrigation, washing, and extraction of tissue and/or debris from the ear canal. It typically consists of a main electromechanical unit that includes a pump for irrigation/infusion of a jet of non-medicated liquid (e.g., saline); controls for the rate and pressure of irrigation; a vacuum extractor, a reservoir for the solution; and a handpiece that may include a set of detachable tips intended for introduction into the ear canal. The system is mainly intended to remove debris (typically cerumen) to clean the ear canal for hygienic purposes, to improve hearing, and before procedures and/or surgery in or through the ear canal.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
914 593-6670chenchenl@allstarmg.com

Regulatory Flags#

DUNS number
548239775
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936189900869CALMING HEATCHNSCC3-3CWT820042024-06-16
06936189900760CALMING HEATCHS3-3CWT55003-318402024-02-19
06936189900777CALMING HEATCHS3-9318412024-02-19
06936189900784CALMING HEATCHNS3-3CWT68104-31908-319172024-02-19
06936189900791CALMING HEATCHNS3-931909-319182024-02-19
06936189900821WUSH31963,V56965,319622024-02-19
06936189900838WUSH319642024-02-19
06936189900852WUSHWUSH12022024-02-19
06936189900753WUSH317692023-03-06
06936189900715SHARPER IMAGECHBWON-3CWT41003-31800-317812022-06-10
06936189900722SHARPER IMAGECHBWON-931801-317822022-06-10
06936189900708SHARPER IMAGECHBWO-3CWT410032022-04-10
06936189900678SHARPER IMAGE25in CHFWU-3CWT310032021-10-20
06936189900685SHARPER IMAGE25in CHFWU-9CWT240032021-10-20
06936189900067SHARPER IMAGE25 in2021-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00714646000729OtoClear SprayWash System, Single UseBionix, LLCLRD2024-07-11
0071464600074327245Bionix, LLCLRD2024-07-11
0071464600075027275Bionix, LLCLRD2024-07-11
00859911004795Tabletop Waterpik Adapter WandsBionix, LLCLRD2024-07-11
00859911004801Portable WaterPik Adapter WandsBionix, LLCLRD2024-07-11
00714646000736OtoClear SprayWash System, Single Use SampleBionix, LLCLRD2024-07-11
10859911004792Tabletop Waterpik Adapter WandsBionix, LLCLRD2024-07-11
00714646000675Ear Wax Removal KitBionix, LLCLRD2024-07-11
00714646001177SprayWash Adapter WandBionix, LLCLRD2023-08-09
00714646000477OtoClear Ear Irrigation System WandsBionix, LLCLRD2023-07-21
10714646000474OtoClear Ear Irrigation System WandsBionix, LLCLRD2023-07-21
06936189900753WUSHGUANGDONG OKAY TECHNOLOGY CO.,LTD.LRD2023-03-06
00714646000965OtoClear® Ear Irrigation System (220V)Bionix, LLCLRD2022-10-27
00714646000972OtoClear® Ear Irrigation System (220V)Bionix, LLCLRD2022-10-27
0071464600098927247Bionix, LLCLRD2022-10-27
00859911004290OtoClear® Spray Wash KitBionix, LLCLRD2022-01-07
00859911004887OtoClear® Aquabot® KitBionix, LLCLRD2022-01-07
00859911004894OtoClear® Aquabot® KitBionix, LLCLRD2022-01-07
05060180256319EXMOOREXMOOR PLASTICS LIMITEDLRD2018-09-10
05060180251963EXMOOREXMOOR PLASTICS LIMITEDLRD2018-09-10
00859911004146Bionix Development CorporationBionix, LLCLRD2017-01-28
00859911004153Bionix Development CorporationBionix, LLCLRD2017-01-28