Duns Number:060944361
Device Description: CareStation Server acquires and displays data from the WCD for clinicians to view.
Catalog Number
80433-002
Brand Name
CareStation Server
Version/Model Number
80433-002
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OUG
Product Code Name
Medical Device Data System
Public Device Record Key
a2888c7b-9406-48ed-b663-a55d7377ffd1
Public Version Date
June 21, 2022
Public Version Number
1
DI Record Publish Date
June 10, 2022
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 | 3 |
| 3 | A medical device with high risk that requires premarket approval | 21 |