Lexie B2, Powered by Bose LBO00001B2

GUDID 00850022464638

Lexie B2, Powered by Bose re-chargeable self-fitting hearing aid

HEARX GROUP (PTY) LTD

Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal Air-conduction hearing aid, receiver-in-canal
Primary Device ID00850022464638
NIH Device Record Keydb6aeb77-43ee-4acd-8373-35908b6beee8
Commercial Distribution StatusIn Commercial Distribution
Brand NameLexie B2, Powered by Bose
Version Model NumberLB2001
Catalog NumberLBO00001B2
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com
Phone(800) 499-1336
Emailsupport@lexiehearing.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850022464638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QDDSelf-Fitting Air-Conduction Hearing Aid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-19
Device Publish Date2022-09-09

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00850022464591 - Go Prime - Beige2024-02-20 Go Prime - Beige - In-store
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
00810153660040 - Go Prime2023-12-26 Go Prime - Black - WAG Online
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