FDA UDI
In Commercial Distribution
🇺🇸 United States
ECCOVISION Rhinometer
DI: 00860719000308
·
Model: 11000
·
SLEEP GROUP SOLUTIONS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ECCOVISION Rhinometer
- Primary DI
- 00860719000308
- Version / Model
- 11000
- Catalog Number
- Legacy 11000
- Company Name
- SLEEP GROUP SOLUTIONS, LLC
- Labeler DUNS
- 039583619
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 4
- Public Version Date
- 2019-03-12
- Public Version Status
- Update
- Public Device Record Key
- 782ee2f0-2728-4fad-b40e-422e6e3b815f
Device Description
The Legacy Rhinometer is used for an objective assessment of nasal cavity geometry
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| BXQ | Rhinoanemometer (Measurement Of Nasal Decongestion) | Anesthesiology | 868.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57974 | Acoustic rhinometer | A line-powered (AC-powered), or powered via a connected computer, electronic device designed to allow the internal profile of the nose to be recorded in order to quantify the degree of obstruction/congestion in the nasal cavities and provide monitoring of the consequences of therapy or surgery. A nosepiece conducts a sound pulse produced by an integrated sound generator to the patient?s nose and the sound reflections from the nose are detected where changes in cross-sectional areas are encountered. It is a computer-based device with dedicated software for processing the outgoing and return signals to produce plots of cross-sectional areas as a function of distance in the nose. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860719000308 | GS1 |
Customer Contacts
- Phone
- 855-475-3374
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K921452 | 000 |