Duns Number:603420183
Device Description: VALVEVAULT™ DEVICE KITThis kit includes one (1) each non-sterile, reusable VALVEVAULT™ DEV VALVEVAULT™ DEVICE KITThis kit includes one (1) each non-sterile, reusable VALVEVAULT™ DEVICE (S), (M), (L), all of which have Direct Marking.
Catalog Number
081040
Brand Name
VALVEVAULT™
Version/Model Number
081040
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
DWS
Product Code Name
INSTRUMENTS, SURGICAL, CARDIOVASCULAR
Public Device Record Key
916439cb-025e-40d5-9816-1c7c94f55632
Public Version Date
February 08, 2021
Public Version Number
1
DI Record Publish Date
January 29, 2021
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 | 56 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |