Duns Number:121170653
Device Description: Multiple Perfusion Set with Vent Line, 15" length, color-coded clamps
Catalog Number
PER-1401S-C05
Brand Name
Surge Cardiovascular
Version/Model Number
PER-1401S-C05
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
ca4db9f7-9469-4909-a930-8c6d09b255c4
Public Version Date
November 02, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
10817278010900
Quantity per Package
10
Contains DI Package
00817278010903
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |