AccessGUDID - DEVICE: Lexie B2, Powered by Bose (00850022464638)

GUDID

Device Identifier (DI) Information

Brand Name: Lexie B2, Powered by Bose
Version or Model: LB2001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LBO00001B2
Company Name: HEARX GROUP (PTY) LTD

Primary DI Number: 00850022464638
Issuing Agency: GS1
Commercial Distribution End Date: November 07, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 539177681 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47169	Air-conduction hearing aid, receiver-in-canal	A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QDD	Self-Fitting Air-Conduction Hearing Aid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211008	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Storage and handling temperature between 0 and 45 degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: db6aeb77-43ee-4acd-8373-35908b6beee8
Public Version Date: October 06, 2023
Public Version Number: 2
DI Record Publish Date: September 09, 2022