Duns Number:097462979
Device Description: Perfusion Set, coronary perfusion, Y-type, 13.5" length Non-Sterile
Catalog Number
PER-1004
Brand Name
Surge Cardiovascular
Version/Model Number
PER-1004
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
-
Product Code
DWF
Product Code Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Public Device Record Key
1e6ff7e1-94a2-4b11-93df-2f74a38a39ba
Public Version Date
September 21, 2022
Public Version Number
4
DI Record Publish Date
March 23, 2018
Package DI Number
10817278011075
Quantity per Package
100
Contains DI Package
00817278011078
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 91 |