FDA.reportPublic FDA data

NA

Primary DI
00385640002431
Brand
NA
Company
Summit Medical, Inc.
Model
EP-1010
Published
2021-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K073401000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073401000EARPOPPER, MODEL EP-2000, EP-2100, EP-3000Micromedics, Inc.2008-03-14MJV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385640002431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385640002431003856400024313856400024310385640002431

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
965484699
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385640072403Quintess®16572026-05-13
00385640072410Quintess®16582026-05-13
00385640091794INSTRUSAFEIN-2020-77532026-05-13
00385640091800INSTRUSAFEIN-2020-78032026-05-13
00385640091817INSTRUSAFEIN-2020-77512026-05-13
00385640091824INSTRUSAFEIN-2020-77932026-05-13
00385640091831INSTRUSAFEIN-2020-77042026-05-13
00385640091848INSTRUSAFEIN-2020-72672026-05-13
00385640091855INSTRUSAFEIN-2550-05-EN-0622026-05-13
00385640091862INSTRUSAFEIN-2550-05-EN-0632026-05-13
00385640091879INSTRUSAFEIN-2550-05-EN-0642026-05-13
00385640091886INSTRUSAFEIN-2550-05-EN-0652026-05-13
00385640091893INSTRUSAFEIN-2600-04-EN-0852026-05-13
00385640091909INSTRUSAFEIN-2020-76362026-05-13
00385640091916INSTRUSAFEIN-2020-76942026-05-13
00385640091923INSTRUSAFEIN-2020-77962026-05-13
00385640091930INSTRUSAFEIN-2020-78852026-05-13
00385640091947INSTRUSAFEIN-2020-78272026-05-13
00385640091954INSTRUSAFEIN-2020-78302026-05-13
00385640091961INSTRUSAFEIN-2020-78292026-05-13

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
06971919466949noneNingbo Albert Novosino Co.,Ltd.MJV2023-10-26
00385640002424InstrusafeSummit Medical, Inc.MJV2016-10-11
00385640023849NASummit Medical, Inc.MJV2016-10-11
00385640023863NASummit Medical, Inc.MJV2016-10-11
00385640023870NASummit Medical, Inc.MJV2016-10-11