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

• Primary Device ID: 00850022464638
• NIH Device Record Key: db6aeb77-43ee-4acd-8373-35908b6beee8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lexie B2, Powered by Bose
• Version Model Number: LB2001
• Catalog Number: LBO00001B2
• Company DUNS: 539177681
• Company Name: HEARX GROUP (PTY) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com
• Phone: (800) 499-1336
• Email: support@lexiehearing.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage and handling temperature between 0 and 45 degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850022464638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211008

FDA Product Code

• QDD: Self-Fitting Air-Conduction Hearing Aid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-19
• Device Publish Date: 2022-09-09

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