FDA.reportPublic FDA data

RCA

Primary DI
00044476153150
Brand
RCA
Company
Voxx Accessories Corp.
Model
RSH05GY
Device description
OTC hearing aid, behind-the-ear design
Published
2023-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QUFHearing Aid, Air-Conduction, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUFHearing Aid, Air-Conduction, Over The CounterEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00044476153150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00044476153150000444761531500444761531500044476153150

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, behind-the-earA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature3 Degrees Celsius46 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
800466695
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00044476158483RCARSH072GY2024-07-26
00044476158605RCARSH082GM2024-04-08
00044476153143RCARSH05BG2023-11-29
00044476153167RCARSH05BK2023-11-29
00044476153266RCARSH052BG2023-11-29
00044476153273RCARSH052GY2023-11-29
00044476153280RCARSH052BK2023-11-29
00044476153198RCARSH20WH2023-11-22
00044476153174RCARSH20BGW2023-10-02
00044476153181RCARSH20GYW2023-10-02
00044476158049RCARSH053BG2023-10-02
00044476158056RCARSH053SL2023-10-02
00044476157417RCARSH062BG2023-09-01
00044476157424RCARSH062SL2023-09-01
00044476157523RCARSH30BG2023-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971094538721KLARIQHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-26
06971094538738KLARIQHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-26
06971094538639Spade & CoHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-24
06971094538615GIATATHAHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-20
06971094538585Bachgold Huizhou Jinghao Medical Technology Co., LtdQUF2026-02-05
06979053570034UltrotingShenzhen Magnet Technology Co., LtdQUF2026-01-21
06979053570041UltrotingShenzhen Magnet Technology Co., LtdQUF2026-01-21
06971094538530LITOULFHuizhou Jinghao Medical Technology Co., LtdQUF2025-12-19
06978898058011Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058028Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058035Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058042Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058059Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058066Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06975958550010MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550119MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550225MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550232MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550249MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550256MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550263MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550270MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550287MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550294MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550300MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550324MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550331MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550362MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550379MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550386MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09