Identity
- Trade Name
- Meniett ® Pulse Generator FDA UDI
- Generic Name
- Middle ear decompressor, positive pressure FDA UDI
- Device Name
- 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 UDI
- Model / Reference
- MT-GEN FDA UDI
- Description
- 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 UDI
Identifiers
- Catalog Number
- MT-GEN FDA UDI
- Primary DI / UDI-DI
- 05708265005062 FDA UDI
- FDA Product Code
- ETY FDA UDI
- GMDN Term
- Middle ear decompressor, positive pressure FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1090 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Middle ear decompressor, positive pressure
Meniett ® Pulse Generator by Lina Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Middle ear decompressor, positive pressure.
- Instrusafe — Summit Medical, LLC · U
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- Meniett ® Pulse Generator- LOANER — Lina Medical ApS · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lina Medical ApS
Sources (1)
- FDA UDI 8493f99a-b759-4843-ab03-7ccd14b2948c 35 fields · synced May 30, 2026