Duns Number:806687406
Device Description: Soft Flow Aortic Catheter 8MM Angled Bulb Vented
Catalog Number
5762
Brand Name
Michigan Critical Care Consultants, Inc.
Version/Model Number
5762
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
Product Code
DWF
Product Code Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Public Device Record Key
e7867e38-f495-44fc-bc15-a57671ce4c39
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
20854916006137
Quantity per Package
10
Contains DI Package
10854916006123
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |