Duns Number:041810693
Device Description: Myocardial Protection System (MPS) 2 console
Catalog Number
-
Brand Name
MPS2 Console
Version/Model Number
5201260
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
-
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
K041979
Product Code
DTR
Product Code Name
Heat-Exchanger, Cardiopulmonary Bypass
Public Device Record Key
0a23d754-a5fa-497e-bdfa-b7fe451aefb1
Public Version Date
December 11, 2019
Public Version Number
4
DI Record Publish Date
August 31, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 168 |
| U | Unclassified | 8 |