Duns Number:058614483
Device Description: Ventilation Dashboard v1.0 Excess Use Subscription
Catalog Number
-
Brand Name
Vital Sync
Version/Model Number
VDASHSUBEXS01
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
K160718
Product Code
DXJ
Product Code Name
DISPLAY, CATHODE-RAY TUBE, MEDICAL
Public Device Record Key
09862ef9-c7a8-4d2d-a75e-016c251d328b
Public Version Date
May 20, 2022
Public Version Number
2
DI Record Publish Date
October 05, 2019
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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |