Duns Number:021063219
Device Description: Polysomnography Sleep System Version 11
Catalog Number
A/ONEBED-SCORE-11X
Brand Name
Polysmith Sleep System
Version/Model Number
A/ONEBED-SCORE-11X
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
-
Product Code
OLT
Product Code Name
Non-normalizing quantitative electroencephalograph software
Public Device Record Key
e63e03cf-6239-4416-ba1c-52522a427659
Public Version Date
December 11, 2019
Public Version Number
4
DI Record Publish Date
May 24, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 393 |