Duns Number:799455241
Device Description: The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
Catalog Number
8700-0782-40
Brand Name
ICY® Intravascular Heat Exchange Catheter Kit EU Applause Custom Luer (Heparin)
Version/Model Number
IC-3893AE
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K101987
Product Code
NCX
Product Code Name
System, Hypothermia, Intravenous, Cooling
Public Device Record Key
302711be-0791-4208-89ee-a7e2bc82aa6c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 30, 2015
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. | 331 |
| 3 | A medical device with high risk that requires premarket approval | 1 |