Duns Number:059636679
Device Description: Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep ap Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
Catalog Number
-
Brand Name
Respire Pink+ H/S with DentiTrac
Version/Model Number
SPPD020US
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 23, 2018
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
K170692
Product Code
PLC
Product Code Name
Sleep Appliances With Patient Monitoring
Public Device Record Key
35a40f3a-6eb3-4559-b081-34cf8ec9283b
Public Version Date
February 17, 2020
Public Version Number
6
DI Record Publish Date
June 19, 2017
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. | 28 |