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MRIaudioPREM1002

FDA UDI

Class II (US FDA UDI)

by Mriaudio

Identity

Trade Name
MRIaudioPREM1002 FDA UDI
Generic Name
Patient audiovisual communication/entertainment system FDA UDI
Device Name
The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. FDA UDI
Model / Reference
1002 FDA UDI
Description
The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection. FDA UDI

Identifiers

Catalog Number
1002 FDA UDI
Primary DI / UDI-DI
B66910021 FDA UDI
510(k) Number
K180100 FDA UDI
FDA Product Code
LNH FDA UDI
GMDN Term
Patient audiovisual communication/entertainment system 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
MRI Safety
MR Conditional FDA UDI

Category: Patient audiovisual communication/entertainment system

MRIaudioPREM1002 by Mriaudio — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient audiovisual communication/entertainment system.

Cleared under the same submission

K180100 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mriaudio

Sources (1)

  • FDA UDI 3eb5f100-36a5-4e81-bed1-0ac69515e682 36 fields · synced May 30, 2026