Zepp Clarity Open Dome L

GUDID 00850051482962

Anhui Huami Information Technology Co., Ltd.

Air-conduction hearing aid, canal
Primary Device ID00850051482962
NIH Device Record Keyda70b7d6-9f54-4dca-a0d0-4ef11a881c7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameZepp Clarity Open Dome L
Version Model NumberA2319Y
Company DUNS421368652
Company NameAnhui Huami Information Technology 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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS100850051482962 [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 Date2023-12-06
Device Publish Date2023-11-28

Devices Manufactured by Anhui Huami Information Technology Co., Ltd.

00850051482931 - Zepp Clarity Tulip Dome 2023-12-06
00850051482948 - Zepp Clarity Open Dome S2023-12-06
00850051482955 - Zepp Clarity Open Dome M2023-12-06
00850051482962 - Zepp Clarity Open Dome L2023-12-06
00850051482962 - Zepp Clarity Open Dome L2023-12-06
00850051482979 - Zepp Clarity Closed Dome S2023-12-06
00850051482986 - Zepp Clarity Closed Dome M2023-12-06
00850051482993 - Zepp Clarity Closed Dome L2023-12-06
00850058994000 - Zepp Clarity Omni2023-12-06

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