Duns Number:748034696
Device Description: The O2Vent OptimaMini is a removable medical device that is fitted in the patient’s mouth The O2Vent OptimaMini is a removable medical device that is fitted in the patient’s mouth and is intended to reduce oralleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aidin the treatment of these conditions.
Catalog Number
O2VBM
Brand Name
O2Vent Optima
Version/Model Number
O2Vent Optima Mini
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K190236
Product Code
LRK
Product Code Name
Device, Anti-Snoring
Public Device Record Key
6052f74a-9f89-4cbc-8a4e-9844e73345dd
Public Version Date
December 10, 2021
Public Version Number
1
DI Record Publish Date
December 02, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |