Duns Number:806687406
Device Description: Soft Flow Aortic 21 FR 7MM STRAIGHT BULB VENTED
Catalog Number
5798
Brand Name
MC3
Version/Model Number
5798
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
K132451,K132451,K132451
Product Code
DWF
Product Code Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Public Device Record Key
892c37a0-f453-4c7f-83bf-3627dfb3e4e7
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
January 10, 2018
Package DI Number
20854916006571
Quantity per Package
10
Contains DI Package
10854916006567
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |