FDA.reportPublic FDA data

MRIaudio Ear-Tip

Primary DI
B6693020
Brand
MRIaudio Ear-Tip
Company
MRIAUDIO, INC.
Model
302
Catalog number
302
Device description
Biocompatible MRIaudio disposable ear-tip certified to 29dB NRR.
Published
2018-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180100000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180100000MRIaudio PREM SystemMriaudio2018-06-14LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B6693001PackageHIBCC500In Commercial Distribution
B6693011PackageHIBCC600In Commercial Distribution
B6693251PackageHIBCC1000In Commercial Distribution
B6693501PackageHIBCC100In Commercial Distribution
B6693020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
HeadphonesA device that is worn on the head, typically fitting over both ears, but that may fit over one ear. It supplies the user with audio input increasing the sound volume of, e.g., television, radio, or a communication amplifier.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8584270679support@mriaudio.com

Regulatory Flags#

DUNS number
026681280
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B66910031MRIaudioPREM1003100310032026-03-31
B66910041MRIaudioPREM1004100410042026-03-31
B66910051MRIaudioPREM1004100510052026-03-31
B66910103G Transducer1011012026-03-06
B6693300MRIaudio Over-Ear Headphones3303302026-03-06
B66915070MRIaudio150715072026-03-03
B66916001MRIaudio1600160016002020-03-16
B66914001MRIaudio1400140014002020-01-30
B66930001MRIview300030002020-01-10
B66935001MRIaudioPREM1000 with MRIview350035002020-01-10
B66935011MRIaudioPREM1001 with MRIview350135012020-01-10
B66910001MRIaudioPREM1000100010002018-10-05
B66910011MRIaudioPREM1001100110012018-10-05
B66910021MRIaudioPREM1002100210022018-10-05
B66910113G Transducer1011012018-10-01
B66915051MRIaudio1505150515052018-10-05
B66915061MRIaudio1506150615062018-10-05
B6693201Wishbone Headset3203202018-10-05
B6693301MRIaudio Over-Ear Headphones3303302018-10-05
B669SMNS00011MRIaudio Siemens SystemSMNS0001SMNS00012018-10-05

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Primary DI, Brand, Company table
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08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
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08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22
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