Duns Number:079991657
Device Description: VAVD-Vacuum Assisted Venous Drainage Controller with Waste Anesthetic Gas Drainage (WAGD) VAVD-Vacuum Assisted Venous Drainage Controller with Waste Anesthetic Gas Drainage (WAGD) and VacPac Mount
Catalog Number
3931
Brand Name
BOEHRINGER® VAVD Controller w/ Waste Gas Drainage & VacPac Mount
Version/Model Number
3931
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
KDP
Product Code Name
Regulator, Vacuum
Public Device Record Key
db06788b-9767-4dff-ad67-14e6d6c50309
Public Version Date
July 09, 2019
Public Version Number
1
DI Record Publish Date
July 01, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85 |