Duns Number:022721133
Device Description: BiNAPS® ADAPTER FOR USE WITH ALICE 5* PSG SYSTEM ALICE 5 is a trademark of Respironics Inc BiNAPS® ADAPTER FOR USE WITH ALICE 5* PSG SYSTEM ALICE 5 is a trademark of Respironics Inc.
Catalog Number
5520-0
Brand Name
BiNAPS
Version/Model Number
5520-0
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
Product Code
BZQ
Product Code Name
Monitor, breathing frequency
Public Device Record Key
1997062d-b245-42d2-9900-8fb3d1dfd9e8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
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 |
|---|---|---|
| 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 |