Vive

Primary DI
10818323023036
Brand
Vive
Company
VIVE HEALTH LLC
Model
LVA1087OS
Device description
Outer Ear Hearing Amplifier (Single)
Published
2019-03-20
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
ESDHearing Aid, Air Conduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818323023036PackageGS1150In Commercial Distribution
00818323023039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302303610818323023036
00818323023039008183230230398183230230390818323023039

GMDN Terms#

Term, Definition table
TermDefinition
Behind-the-ear air-conduction hearing aidA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00810041982483ViveLVA2057BLU2026-05-14
00818323022797ViveLVA1003PAK2 2026-05-11
00818323025279ViveLVA10032026-05-11
00810113576817ViveLVA3049BLKML6M72024-07-17
00810113576824ViveLVA3049BLKCM92024-07-17
00810113576831ViveLVA3049BLKBM62024-07-17
00810113579627ViveLVA3078WHTS2025-04-04
00810113579634ViveLVA3078WHTM2025-04-04
00810113579641ViveLVA3078WHTL2025-04-04
00810113579658ViveLVA3078WHTL2025-04-04
00810178883516ViveLVA3099BLK2025-07-17
00818323025002VIVELVA1099BLK2019-03-24
00818323025019VIVELVA1099GRY2019-03-24
00818323025026VIVELVA1099PUR2019-03-24
00810178883639ViveLVA3102BLK2025-08-07
00810178883301ViveLVA3098BLK2025-07-17
00810178883523ViveLVA3100BLK2025-07-17
00810178883530ViveLVA3100PUR2025-07-17
00810178881857ViveLVA3086BLUS2025-07-15
00810178881864ViveLVA3086BLUM2025-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840388201145STARKEYStarkey Laboratories, Inc.ESD2025-06-25
00840388201541STARKEYStarkey Laboratories, Inc.ESD2025-06-25
00840388201640AUDIBELStarkey Laboratories, Inc.ESD2025-06-25
00840388201657AUDIBELStarkey Laboratories, Inc.ESD2025-06-25
00840388201664AUDIBELStarkey Laboratories, Inc.ESD2025-06-25
00840388201695NUEARStarkey Laboratories, Inc.ESD2025-06-25
00840388201701NUEARStarkey Laboratories, Inc.ESD2025-06-25
00840388201725MICROTECHStarkey Laboratories, Inc.ESD2025-06-25
00840388201732MICROTECHStarkey Laboratories, Inc.ESD2025-06-25
00840388201763AUDIGYStarkey Laboratories, Inc.ESD2025-06-25
00840388201770AUDIGYStarkey Laboratories, Inc.ESD2025-06-25
00840388201787AUDIGYStarkey Laboratories, Inc.ESD2025-06-25
00840388201794AUDIGYStarkey Laboratories, Inc.ESD2025-06-25
00840388201886AMPLIFONStarkey Laboratories, Inc.ESD2025-06-25
00840388201909AMPLIFONStarkey Laboratories, Inc.ESD2025-06-25
07613389772838ampli-mini I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772845ampli-mini I 2 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772920MEMINI I 4 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772937MEMINI I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
16945936703773NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
00810126191373AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191380AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191397AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191403AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191410AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191427AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191434AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191441AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191458AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191465AudinaAudina Hearing Instruments, Inc.ESD2023-01-31