Duns Number:809699023
Device Description: BioFlo Plastic Port with PASV Valve Technology (Filled Suture Holes) and 6F x 63cm Polyur BioFlo Plastic Port with PASV Valve Technology (Filled Suture Holes) and 6F x 63cm Polyurethane Catheter with ENDEXO Technology
Catalog Number
-
Brand Name
BioFlo
Version/Model Number
44020
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
LJT
Product Code Name
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Public Device Record Key
f87a184c-6512-45c3-bce1-53c75084d68b
Public Version Date
May 24, 2021
Public Version Number
4
DI Record Publish Date
September 14, 2015
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 | 71 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1641 |