Duns Number:060944361
Device Description: The ASSURE Wearable Cardioverter Defibrillator System
Catalog Number
80014-001
Brand Name
ASSURE WCD System
Version/Model Number
80014-001
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
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
P200037,P200037,P200037,P200037
Product Code
MVK
Product Code Name
Wearable Automated External Defibrillator
Public Device Record Key
1ec079ac-314d-43ad-a010-9bfca975c2a3
Public Version Date
January 12, 2022
Public Version Number
2
DI Record Publish Date
November 15, 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 | 3 |
| 3 | A medical device with high risk that requires premarket approval | 21 |