Duns Number:800432093
Device Description: The Daily Cardiac Cooling Jacket is a conformable heat exchanger which is placed around th The Daily Cardiac Cooling Jacket is a conformable heat exchanger which is placed around the heart during cardiopulmonary bypass procedures. By circulating cold physiologic saline through the jacket the heat is transferred from the heart to the solution thus reducing the heart temperature to provide myocardial preservation. The device is used as an alternative to iced slush for topical cardiac hypothermia.
Catalog Number
-
Brand Name
Daily Cardiac Cooling Jacket
Version/Model Number
C1116, C1123, C1130
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DWC
Product Code Name
Controller, Temperature, Cardiopulmonary Bypass
Public Device Record Key
1efed18e-934b-4c45-b5f4-76c000b04b68
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 02, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |