FDA.reportPublic FDA data

n/a

Primary DI
06980134820115
Brand
n/a
Company
Blue Deer Medical Equipment (guangdong) Co., Ltd.
Model
BD-B101
Device description
This hearing aid is suitable for mild, moderate to severe hearing loss, with mode switching for various scenarios, classic design and comfortable accessories. It features comfortable wearing, pure and thick sound quality with high restoration for pleasant listening, lithium battery power and magnetic charging for cyclic use.
Published
2026-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06980134820115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06980134820115069801348201156980134820115

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.

Regulatory Flags#

DUNS number
456587027
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
06980134820016n/aBD-B101A2026-06-09
06980134820023n/aDR64012026-06-09
06980134820030n/aBD-I101A2026-06-09
06980134820047n/aRC07-022026-06-09
06980134820054n/aE082026-06-09
06980134820061n/aBD-B1022026-06-09
06980134820078n/aBD-E101A2026-06-09
06980134820085n/aBD-E1012026-06-09
06980134820092n/aBD-E1022026-06-09
06980134820108n/aBD-I102A2026-06-09
06980134820122n/aBD-S1022026-06-09
06980134820139n/aBD-S1012026-06-09
06980134820146n/aBD-B1042026-06-09
06980134820153n/aBD-C1032026-06-09
06980134820160n/aBD-C1032026-06-09
06980134820177n/aBD-C1012026-06-09
06980134820184n/aBD-C1012026-06-09
06980134820191n/aBD-N101A2026-06-09
06980134820207n/aBD-B1052026-06-09
06980134820214n/aFi62026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06980134820016n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820023n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820030n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820047n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820054n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820061n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820078n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820085n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820092n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820108n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820122n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820139n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820146n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820153n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820160n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820177n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820184n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820191n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820207n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820214n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820221n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820238n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820245n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820252n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820269n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820276n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820283n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06973967150658EaraXiamen Vienatone Medical Technology Co., Ltd.QUG2026-05-19
06971094538677AntOkayHuizhou Jinghao Medical Technology Co., LtdQUG2026-05-01
06973967150351Audien HearingXiamen Vienatone Medical Technology Co., Ltd.QUG2026-04-28