FDA.reportPublic FDA data

NeilMed Eustachi

Primary DI
00705928603691
Brand
NeilMed Eustachi
Company
NEILMED PHARMACEUTICALS, INC.
Model
ME8203
Device description
NeilMed Eustachi is an active device intended to exchange pressure in ear cavity to treat negative middle ear pressure.
Published
2026-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K203754000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203754000Eustachi Ear Pressure Relief DeviceExercore, LLC2021-02-19MJV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00705928603691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00705928603691007059286036917059286036910705928603691

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure21 Inches of Mercury32 Inches of Mercury
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-877-477-8633questions@neilmed.com

Regulatory Flags#

DUNS number
799295915
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00705928002043NeilMed Sinus RinsePediatric, 120 Premixed Sachets2023-03-02
00705928003002NeilMed Sinus RinsePediatric, 60 Premixed Sachets2023-03-02
00705928003101Sinus Rinse KitIsotonic, 10ct Packets/Sachets2023-03-02
00705928004009NeilMed Sinus Rinse Refill BoxHypertonic, 70 Premixed Packets2023-03-02
00705928014008NeilMed Sinus Rinse KitPediatric, 30ct Packets/Sachets2023-03-02
00705928052000NeilMed Sinus Rinse Refill BoxIsotonic, 50ct Packets/Sachets2023-03-02
00705928652101NeilMed Wound WashWoundWashWW-0NB-48-ENU-USL2020-08-28
00705928001008NeilMed Sinus RinseNeilMed Sinus Rinse Kit 60 Premixed Sachets2022-10-17
00705928000995NeilMed NasogelNasogel TubeNG-6R-96-ENU-USL2022-07-04
00705928045309NeilMed NasogelNasogel SprayGSP30-6R-96-ENU-USL2022-07-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014369506EarfloEARFLO, INC.MJV2026-03-31
06971919466949noneNingbo Albert Novosino Co.,Ltd.MJV2023-10-26
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