Primary Device ID | B6693020 |
NIH Device Record Key | 0a1c702e-c162-400f-bce8-2ac10fa036f8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MRIaudio Ear-Tip |
Version Model Number | 302 |
Catalog Number | 302 |
Company DUNS | 026681280 |
Company Name | MRIAUDIO, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Safe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 8584270679 |
support@mriaudio.com | |
Phone | 8584270679 |
support@mriaudio.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B6693001 [Package] Package: Tub/Jar [500 Units] In Commercial Distribution |
HIBCC | B6693011 [Package] Package: Tub/Jar [600 Units] In Commercial Distribution |
HIBCC | B6693020 [Primary] |
HIBCC | B6693251 [Package] Package: Tub/Jar [1000 Units] In Commercial Distribution |
HIBCC | B6693501 [Package] Package: Tub/Jar [100 Units] In Commercial Distribution |
LNH | System, Nuclear Magnetic Resonance Imaging |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-11-14 |
Device Publish Date | 2018-10-05 |
B66916001 - MRIaudio1600 | 2020-03-24 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and h |
B66914001 - MRIaudio1400 | 2020-02-07 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and h |
B66930001 - MRIview | 2020-01-20 The MRIview is an MRI conditional video solution that provides MRI patients with visual entertainment. |
B66935001 - MRIaudioPREM1000 with MRIview | 2020-01-20 The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visu |
B66935011 - MRIaudioPREM1001 with MRIview | 2020-01-20 The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visu |
B66910001 - MRIaudioPREM1000 | 2019-11-14 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and h |
B66910011 - MRIaudioPREM1001 | 2019-11-14 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and h |
B66910021 - MRIaudioPREM1002 | 2019-11-14 The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and h |