FDA UDI
In Commercial Distribution
🇺🇸 United States
MRIaudio Ear-Tip
DI: B6693020
·
Model: 302
·
MRIAUDIO, INC.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
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Basic Information
- Brand Name
- MRIaudio Ear-Tip
- Primary DI
- B6693020
- Version / Model
- 302
- Catalog Number
- 302
- Company Name
- MRIAUDIO, INC.
- Labeler DUNS
- 026681280
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-05
- Public Version
- 3
- Public Version Date
- 2026-03-09
- Public Version Status
- Update
- Public Device Record Key
- 0a1c702e-c162-400f-bce8-2ac10fa036f8
Device Description
Biocompatible MRIaudio disposable ear-tip certified to 29dB NRR.
Device Characteristics
- Single Use
- Yes
- 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 Safe
- 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 |
|---|---|---|---|---|
| 30075 | Headphones | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B6693020 | HIBCC | ||||
| Package | B6693501 | HIBCC | Tub/Jar | 100 | In Commercial Distribution | |
| Package | B6693251 | HIBCC | Tub/Jar | 1000 | In Commercial Distribution | |
| Package | B6693011 | HIBCC | Tub/Jar | 600 | In Commercial Distribution | |
| Package | B6693001 | HIBCC | Tub/Jar | 500 | In Commercial Distribution |
Customer Contacts
- Phone
- 8584270679
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180100 | 000 |