AccessGUDID - DEVICE: RCA (00044476157417)

GUDID

Device Identifier (DI) Information

Brand Name: RCA
Version or Model: RSH062BG
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Voxx Accessories Corp.

Primary DI Number: 00044476157417
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 800466695 *Terms of Use

Device Description: OTC hearing aids, behind-the-ear micro design, 4 preset hearing modes, 11 volume levels, with rechargeable lithium battery, charging case and power adapter included.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	No
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?
34671	Air-conduction hearing aid, behind-the-ear	A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). 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 through an earmould that fits inside the outer ear or a tube in the ear canal. 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
QUF	Hearing Aid, Air-Conduction, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a8cc504d-c784-4bdf-9b45-16ad4611555c
Public Version Date: September 11, 2023
Public Version Number: 1
DI Record Publish Date: September 01, 2023