none

Primary DI
06971919466949
Brand
none
Company
Ningbo Albert Novosino Co.,Ltd.
Model
ER813B
Published
2023-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
MJVDevice, Inflation, Middle Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJVDevice, Inflation, Middle EarUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230502000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230502000Ear Pressure Relief Device(Model:ER813B)Ningbo Albert Novosino Co., Ltd.2023-06-09MJV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971919466949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971919466949069719194669496971919466949

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear decompressor, positive pressureA manual device intended to reduce the symptoms associated with negative air pressure in the middle ear by increasing air pressure in the Eustachian tube, to counter/prevent certain physical states or thick fluid accumulation behind the eardrum. It typically consists of a manually-operated deflator/inflator (e.g., balloon) connected to an applicator (e.g., nosepiece, mouthpiece, face mask). This is a reusable device typically used in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543014978
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16971919462528Medi Grade2L2025-12-29
16971919462535Medi Grade60ml2025-12-29
16971919460500Medi Grade20ML2025-11-20
16971919460449Medi Grade500ml2025-11-17
16971919460494Medi Grade90ml2025-11-17
16971919460432Medi Grade75ml2025-11-11
06971919462156noneIBS0012025-03-14
06971919460602BieglerJR60010002024-05-24
06971919460619BieglerJR60030002024-05-24
06971919460626BieglerJR50502012024-05-24
06971919460633BieglerJR60602012024-05-24
06971919460657BieglerJR50503012024-05-24
06971919460664BieglerJR60603012024-05-24
06971919461395PREMIUM2L2024-03-11
06971919461401PREMIUM2L2024-03-11
06971919460725ClarifloRU1000PGS2023-04-20
06971919460732ClarifloRU3000PGS2023-04-20
09369998205660Migraine stopper1.02023-05-31
06971919466253Migraine StopperA/02022-08-09
06971919460336BieglerJR50005002023-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00705928603691NeilMed EustachiNEILMED PHARMACEUTICALS, INC.MJV2026-04-27
00860014369506EarfloEARFLO, INC.MJV2026-03-31
00385640002431NASummit Medical, Inc.MJV2021-05-18
00385640002424InstrusafeSummit Medical, Inc.MJV2016-10-11
00385640023849NASummit Medical, Inc.MJV2016-10-11
00385640023863NASummit Medical, Inc.MJV2016-10-11
00385640023870NASummit Medical, Inc.MJV2016-10-11