3G Transducer 101

GUDID B6691011

3rd generation MRIaudio Premium Transducer. Provides patients with high fidelity sound. 1.5 and 3 Tesla tested. Includes pneumatic tubing.

MRIAUDIO, INC.

Patient audiovisual communication/entertainment system
Primary Device IDB6691011
NIH Device Record Key981367c2-6fe0-4aa4-8139-96168c029c6a
Commercial Distribution StatusIn Commercial Distribution
Brand Name3G Transducer
Version Model Number101
Catalog Number101
Company DUNS026681280
Company NameMRIAUDIO, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8584270679
Emailsupport@mriaudio.com
Phone8584270679
Emailsupport@mriaudio.com
Phone8584270679
Emailsupport@mriaudio.com
Phone8584270679
Emailsupport@mriaudio.com
Phone8584270679
Emailsupport@mriaudio.com
Phone8584270679
Emailsupport@mriaudio.com
Phone8584270679
Emailsupport@mriaudio.com
Phone8584270679
Emailsupport@mriaudio.com
Phone8584270679
Emailsupport@mriaudio.com
Phone8584270679
Emailsupport@mriaudio.com
Phone8584270679
Emailsupport@mriaudio.com
Phone8584270679
Emailsupport@mriaudio.com
Phone8584270679
Emailsupport@mriaudio.com
Phone8584270679
Emailsupport@mriaudio.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB6691011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNHSystem, Nuclear Magnetic Resonance Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-14
Device Publish Date2018-10-01

On-Brand Devices [3G Transducer]

B66910113rd generation MRIaudio Premium Transducer. Provides patients with high fidelity sound. 1.5 and
B66910103rd generation MRIaudio Premium Transducer. Provides patients with high fidelity sound. 1.5 and

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