FDA UDI
In Commercial Distribution
🇺🇸 United States
MRIaudioPREM1001 with MRIview
DI: B66935011
·
Model: 3501
·
MRIAUDIO, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MRIaudioPREM1001 with MRIview
- Primary DI
- B66935011
- Version / Model
- 3501
- Catalog Number
- 3501
- Company Name
- MRIAUDIO, INC.
- Labeler DUNS
- 026681280
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-10
- Public Version
- 2
- Public Version Date
- 2026-03-09
- Public Version Status
- Update
- Public Device Record Key
- 69d93b4e-742f-4f49-a27d-b157d3e43250
Device Description
The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visual entertainment, direct communication, and hearing protection.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | 892.1000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64404 | Patient audiovisual communication/entertainment system | An assembly of devices intended to be used to provide a communication and/or entertainment channel for a patient undergoing a radiological examination (e.g., MRI scan). It typically consists of a control unit, intercom, and data communication hub; with earplugs, or other personal audio device, and/or a visual monitor for the patient. It may be supplied in a modular fashion. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B66935011 | HIBCC |
Customer Contacts
- Phone
- 8584270679
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193102 | 000 |