Lexie B1, Powered by Bose

GUDID 00850022464492

Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids

HEARX GROUP (PTY) LTD

Air-conduction hearing aid, receiver-in-canal
Primary Device ID00850022464492
NIH Device Record Key4270b3ac-15ab-4cc2-b88a-4d1878fb79e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameLexie B1, Powered by Bose
Version Model NumberLB1001
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100017817827416 [Previous]
GS100850022464492 [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 Date2022-08-09
Device Publish Date2022-08-01

Devices Manufactured by HEARX GROUP (PTY) LTD

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00810153660217 - Go Prime - Black2024-08-27 Go Prime - Black - Amazon
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
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