FDA.reportPublic FDA data

Zepp Clarity ONE Ear Tips Kit

Primary DI
06972596104513
Brand
Zepp Clarity ONE Ear Tips Kit
Company
Anhui Huami Information Technology Co., Ltd.
Model
A2204Y
Published
2022-03-10
Public version status
New
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972596104513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972596104513069725961045136972596104513

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945936705701QuietlyBoldXiamen New Sound Technology Co., Ltd.OSM2026-06-09
05714880295719SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295726SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295733SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295740SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295788SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295795SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295849SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295856SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295900SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295917SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295986SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296013SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296044SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296075SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296105SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880293531SIGNIAWs Audiology Usa, Inc.OSM2026-06-04
05714880297898SIGNIAWs Audiology Usa, Inc.OSM2026-06-04
06945936705688NewSoundXiamen New Sound Technology Co., Ltd.OSM2026-06-02
07613389836325DVD Phonak Target 12.0Sonova AGOSM2026-06-01
07613389836332USB Phonak Target 12.0 USBSonova AGOSM2026-06-01
07613389836349Phonak Target 12.0Sonova AGOSM2026-06-01
07613389842388Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389842395Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389842401Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389843026Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389917024Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
07613389917116Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
07613389917123Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
05714880113778CONNEXXWs Audiology Usa, Inc.OSM2026-05-28