Duns Number:809699023
Device Description: 15.5Fx20cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Kit
Catalog Number
-
Brand Name
BioFlo
Version/Model Number
02-901
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
MSD
Product Code Name
Catheter, hemodialysis, implanted
Public Device Record Key
9b74301c-7c46-49cb-aeb2-8f35e3dcfe1b
Public Version Date
May 05, 2021
Public Version Number
4
DI Record Publish Date
September 17, 2015
Package DI Number
H965103029011
Quantity per Package
5
Contains DI Package
H965103029010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 71 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1641 |