MRIaudio1600 - The MRIaudio PREM system is an MRI conditional - MRIAUDIO, INC.

Duns Number:026681280

Device Description: The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients w The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.

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More Product Details

Catalog Number

1600

Brand Name

MRIaudio1600

Version/Model Number

1600

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K180100

Product Code Details

Product Code

LNH

Product Code Name

System, Nuclear Magnetic Resonance Imaging

Device Record Status

Public Device Record Key

d5708fbc-181a-4f40-97d2-132fbb101936

Public Version Date

March 24, 2020

Public Version Number

1

DI Record Publish Date

March 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MRIAUDIO, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14