Duns Number:316153865
Device Description: PLEGIOX Heat Exchanger, SOFTLINE coated, Sterile. The PLEGIOX cardioplegia heat exchanger PLEGIOX Heat Exchanger, SOFTLINE coated, Sterile. The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The PLEGIOX contains heat exchanger fibers through which the cooling or heating fluid is pumped. The fluid to be temperature-controlled flows around the outside of these fibers. Deairing is ensured by a bubble trap with a filter integrated in the upper part of the PLEGIOX. An integrated bypass stopcock enables hot-shot to be performed.
Catalog Number
70103.4981
Brand Name
PLEGIOX Cardioplegia Heat Exchanger
Version/Model Number
BO-CHX 30, SOFTLINE, Sterile
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112360,K112360
Product Code
DTM
Product Code Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Public Device Record Key
c137f443-d2ae-4ef6-bc98-e6f0a982d3af
Public Version Date
December 11, 2019
Public Version Number
4
DI Record Publish Date
March 13, 2017
Package DI Number
04037691229584
Quantity per Package
8
Contains DI Package
04037691229591
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 286 |