Device
NeilMed Eustachi is an active device intended to exchange pressure in ear cavity to treat negative middle ear pressure.
Manufacturer
NEILMED PHARMACEUTICALS, INC.
NEILMED PHARMACEUTICALS, INC.
Model: ME8203
DI: 00705928603691
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-04-27
Current Version: 2026-05-05
Description
NeilMed Eustachi is an active device intended to exchange pressure in ear cavity to treat negative middle ear pressure.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1778fed4-d9ae-4a8f-b69a-b548604cf19b
Distribution Status:
In Commercial Distribution
DUNS Number:
799295915
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
00705928603691
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47542
Name: Middle ear decompressor, positive pressure
Definition:
A 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.
FDA Product Codes
MJV
Device, Inflation, Middle Ear
Premarket Submissions
Submission Number:
K203754
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling High - @attributes - Value:
90
Item #1 - Storage Handling Type:
Storage Environment Humidity
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
-25
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
70
Item #2 - Storage Handling Type:
Storage Environment Temperature
Item #3 - Storage Handling Low - @attributes - Unit:
Inches of Mercury
Item #3 - Storage Handling Low - @attributes - Value:
21
Item #3 - Storage Handling High - @attributes - Unit:
Inches of Mercury
Item #3 - Storage Handling High - @attributes - Value:
32
Item #3 - Storage Handling Type:
Handling Environment Atmospheric Pressure
Item #4 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #4 - Storage Handling Low - @attributes - Value:
15
Item #4 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #4 - Storage Handling High - @attributes - Value:
90
Item #4 - Storage Handling Type:
Handling Environment Humidity
Item #5 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #5 - Storage Handling Low - @attributes - Value:
5
Item #5 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #5 - Storage Handling High - @attributes - Value:
40
Item #5 - Storage Handling Type:
Handling Environment Temperature