Duns Number:006261481
Device Description: CANN CB96570-019 BIO-MEDICUS 19FR
Catalog Number
-
Brand Name
Bio-Medicus™
Version/Model Number
CB96570-019
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 21, 2019
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K924642
Product Code
DWF
Product Code Name
Catheter, cannula and tubing, vascular, cardiopulmonary bypass
Public Device Record Key
e7e11bc3-2fd9-4113-9958-12e6e5e3d1d6
Public Version Date
September 22, 2022
Public Version Number
2
DI Record Publish Date
November 24, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |