Identity
- Trade Name
- MRIaudio Over-Ear Headphones FDA UDI
- Generic Name
- Headphones FDA UDI
- Device Name
- MRI-safe ear defenders provide patients with 29dB of hearing protection and allow patients to listen to audio entertainment. Do NOT require earplugs to achieve 29dB NRR. Standard two prong pneumatic headphone connection. FDA UDI
- Model / Reference
- 330 FDA UDI
- Description
- MRI-safe ear defenders provide patients with 29dB of hearing protection and allow patients to listen to audio entertainment. Do NOT require earplugs to achieve 29dB NRR. Standard two prong pneumatic headphone connection. FDA UDI
Identifiers
- Catalog Number
- 330 FDA UDI
- Primary DI / UDI-DI
- B6693301 FDA UDI
- 510(k) Number
- K180100 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- Headphones FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Headphones
MRIaudio Over-Ear Headphones by Mriaudio — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K180100 also covers:
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
- Mriaudio
Sources (1)
- FDA UDI e5cb6348-e372-40be-979c-bb14aed13148 36 fields · synced Jun 8, 2026