Duns Number:022721133
Device Description: SnoreTAC® adapter replaces the Snore Microphone when used with BiNAPS®. Use during CPAP T SnoreTAC® adapter replaces the Snore Microphone when used with BiNAPS®. Use during CPAP Titration.
Catalog Number
5531-0
Brand Name
BiNAPS
Version/Model Number
5531-0
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"
Yes
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
K151874,K151874
Product Code
BZQ
Product Code Name
Monitor, breathing frequency
Public Device Record Key
56bb526c-57b6-469d-8760-bbeae65b1e60
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10607411801133
Quantity per Package
50
Contains DI Package
00607411801136
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |