Duns Number:041810693
Device Description: MPS® Retrograde external pressure line w/pressure transducer
Catalog Number
-
Brand Name
MPS
Version/Model Number
5051101
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K953838,K953838
Product Code
DTR
Product Code Name
Heat-Exchanger, Cardiopulmonary Bypass
Public Device Record Key
b3df9b6f-33dd-4100-af15-0cee79313ff8
Public Version Date
October 19, 2021
Public Version Number
4
DI Record Publish Date
September 16, 2015
Package DI Number
20634624551118
Quantity per Package
10
Contains DI Package
00634624551114
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 168 |
| U | Unclassified | 8 |