FDA.reportPublic FDA data

ZEPP CLARITY ONE Earwax Guard

Primary DI
06972596104773
Brand
ZEPP CLARITY ONE Earwax Guard
Company
Anhui Huami Information Technology Co., Ltd.
Model
A2205Y
Published
2022-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air Conduction With Wireless Technology
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972596104773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972596104773069725961047736972596104773

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, canalA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. It is used for mild to moderately-severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421368652
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850051482931Zepp Clarity Tulip Dome A2316Y2023-11-28
00850051482948Zepp Clarity Open Dome SA2317Y2023-11-28
00850051482955Zepp Clarity Open Dome MA2318Y2023-11-28
00850051482962Zepp Clarity Open Dome LA2319Y2023-11-28
00850051482979Zepp Clarity Closed Dome SA231AY2023-11-28
00850051482986Zepp Clarity Closed Dome MA231BY2023-11-28
00850051482993Zepp Clarity Closed Dome LA231CY2023-11-28
00850058994000Zepp Clarity OmniA23172023-11-28
00850058994017Zepp Clarity RIC Wire Size 1 LeftA231DY2023-11-28
00850058994024Zepp Clarity RIC Wire Size 1 RightA231EY2023-11-28
00850058994031Zepp Clarity RIC Wire Size 2 LeftA231FY2023-11-28
00850058994048Zepp Clarity RIC Wire Size 2 RightA2320Y2023-11-28
00850058994055Zepp Clarity RIC Wire Size 3 LeftA2321Y2023-11-28
00850058994062Zepp Clarity RIC Wire Size 3 RightA2322Y2023-11-28
00850051482832Zepp Clarity OmniA23172023-11-27
00850051482306Zepp Clarity PixieA22852023-08-16
00850051482313Zepp Clarity Pixie Open Dome SA2310Y2023-08-16
00850051482320Zepp Clarity Pixie Open Dome MA2311Y2023-08-16
00850051482337Zepp Clarity Pixie Closed Dome SA2312Y2023-08-16
00850051482344Zepp Clarity Pixie Closed Dome MA2313Y2023-08-16

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