Lexie B2 Plus Powered by Bose LBS00001B2PLS

GUDID 00850022464973

Lexie B2 Plus Powered by Bose

HEARX GROUP (PTY) LTD

Air-conduction hearing aid, receiver-in-canal
Primary Device ID00850022464973
NIH Device Record Keydd1bd9a0-223a-4ffb-89cc-aa8d32dd621a
Commercial Distribution StatusIn Commercial Distribution
Brand NameLexie B2 Plus Powered by Bose
Version Model NumberLexie Hearing
Catalog NumberLBS00001B2PLS
Company DUNS539177681
Company NameHEARX GROUP (PTY) LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850022464973 [Primary]

FDA Product Code

QUHSelf-Fitting Air-Conduction Hearing Aid, 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 Date2024-02-08
Device Publish Date2024-01-31

Devices Manufactured by HEARX GROUP (PTY) LTD

00810153660187 - Go Prime - Beige2024-05-27 Go Prime - Beige - In-store
00810153660149 - Lexie Hearing2024-03-15
00810153660156 - Lexie Hearing2024-03-15
00810153660163 - Lexie Hearing2024-03-15
00850022464591 - Go Prime - Beige2024-02-20 Go Prime - Beige - In-store
00850022464973 - Lexie B2 Plus Powered by Bose2024-02-08Lexie B2 Plus Powered by Bose
00850022464973 - Lexie B2 Plus Powered by Bose2024-02-08 Lexie B2 Plus Powered by Bose
00810153660057 - Go Hearing2024-01-23 Go Hearing - Go Ultra - Gray - BTE - WAG Online
10810153660054 - Go Hearing2024-01-23 Go Hearing - Go Ultra - Gray - BTE - WAG Online - CASE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.