Duns Number:809699023
Device Description: 14.5F x 37cm Vaxcel Plus Chronic Dialysis Catheter with Metal Tunneler and 3 Introducer Ne 14.5F x 37cm Vaxcel Plus Chronic Dialysis Catheter with Metal Tunneler and 3 Introducer Needle Sizes
Catalog Number
-
Brand Name
Vaxcel
Version/Model Number
45554
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 02, 2021
Issuing Agency
In HIBCC
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
a9d36722-456a-44c5-9ac1-409014ab80ae
Public Version Date
November 03, 2021
Public Version Number
4
DI Record Publish Date
October 19, 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 |