Duns Number:079605674
Device Description: The WAVE Clinical Platform software displays, routes, and stores medical device and diagno The WAVE Clinical Platform software displays, routes, and stores medical device and diagnostic information from supported devices.
Catalog Number
-
Brand Name
WAVE Clinical Platform
Version/Model Number
NG
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
K171056
Product Code
MWI
Product Code Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Public Device Record Key
2db7d593-7603-4978-8f06-2e598421cace
Public Version Date
November 08, 2018
Public Version Number
4
DI Record Publish Date
January 29, 2018
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. | 1 |