FDA.reportPublic FDA data

NuvoMed

Primary DI
00810110301436
Brand
NuvoMed
Company
NUVOMED, INC.
Model
HNB-4/0143
Device description
DigiEars / LIGHT Bluetooth Neckband Hearing Aid
Published
2022-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00810110301436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810110301436008101103014368101103014360810110301436

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid neck induction loop, wireless inputA portable, battery-powered device worn around the neck intended to receive sound from an audio source [e.g., mobile (cellular) telephone] wirelessly (e.g., via Bluetooth) and transfer it via an audio frequency magnetic field to a hearing aid with an induction coil (i.e., bypassing the hearing aids microphone) when it is switched to the "T" or `?MT?? position, in order for the hearing aid user to hear (e.g., telephone conversation, music) more clearly. It typically consists of small active amplifier with a wire loop worn around the neck. It may also include a microphone for hands-free telephone conversation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080809709
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810110303812NuvomedWDT-16/03812026-08-19
00810110305014NuvomedKDT-16/05012026-08-19
00859811007063NuvoMedBGTS50-24/07682018-09-04
00859811007681NuvoMed BGTS50-24/07682018-08-28
00859811009241NuvoMedTDT-6/09242020-10-30
00859811009234NuvoMedTBP-6/09232020-10-30
00859811009258NuvoMedTOS-6/09252020-10-30
00810110302099NuvoMedCTSS-12/02092024-03-22
00810110302105NuvoMedCTSL-12/02102024-03-22
00810110302112NuvoMedCTSX-12/02112024-03-22
00810110302129NuvoMedCTFP-6/02122024-03-22
00810110303492NuvoMedNWBP-6/03492024-10-18
00810110303508NuvoMedNABP-6/03502024-10-18
00810110303676NuvoMedLOS-12/03672024-12-13
00859811008947NuvoMedDCT-6/08942024-12-13
00859811007391NuvoMedFPO-6/07392018-09-10
00859811007261NuvoMedNGS50-24/07262019-01-29
00859811007414NuvomedMBG10-6/07412019-01-29
00810110302075NuvoMedBPMC-6/02072023-12-05
00859811007025NuvoMedNIET-6/07022018-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979809410003Hearing AidsShenzhen Anker Medical Devices Co., Ltd.QUG2026-09-22
06943786094839AUDIENAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2026-09-20
06977352080612ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080629ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080681ELEHEARELEHEAR Inc.QUG2026-09-05
06977352080698ELEHEARELEHEAR Inc.QUG2026-09-05
06974608620523PHONELUMShenzhen Eartech Co., Ltd.QUG2026-08-27
00850080488577flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-08-25
00850080488584flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-08-25
00850065321967CeretoneAudicon CorporationQUG2026-08-14
06943786094846AUSTARAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2026-08-14
08056262819890nuance audioLUXOTTICA GROUP SPAQUG2026-07-31
08056262856789nuance audioLUXOTTICA GROUP SPAQUG2026-07-31
06980305290013CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290020CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290037CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290044CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290068CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290082CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290099CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290105CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290112CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290129CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
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