Duns Number:809699023
Device Description: Vaxcel Plastic Standard Port with PASV Valve and 8F x 63cm Polyurethane Catheter
Catalog Number
-
Brand Name
Vaxcel
Version/Model Number
45366
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 02, 2021
Issuing Agency
In HIBCC
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
546bc1b0-6e79-4893-88a8-a5e485bb0a8e
Public Version Date
November 04, 2021
Public Version Number
3
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 |