Duns Number:790268031
Device Description: Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV
Catalog Number
CD3369-40QC
Brand Name
QUADRA ASSURA MP™
Version/Model Number
CD3369-40QC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
Yes
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
NIK
Product Code Name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Public Device Record Key
46da966a-b34c-4edf-9e37-42c2ed59d3d4
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
March 23, 2016
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 | 70 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1429 |
| 3 | A medical device with high risk that requires premarket approval | 736 |