Duns Number:799455241
Device Description: The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter d The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.
Catalog Number
-
Brand Name
Cool Line® Intravascular Heat Exchange Catheter Kit Japan, Final Pkged Kit Ne
Version/Model Number
CL-2295
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
eb493b66-dd4f-41d5-a3c1-22d9c93af11a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 10, 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 |
|---|---|---|
| 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 |