Duns Number:961027315
Device Description: VASCATH INSERTION PACK
Catalog Number
SANVAPIGMB
Brand Name
CARDINAL HEALTH
Version/Model Number
SANVAPIGMB
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"
Yes
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
PXK
Product Code Name
Vascular access port kit
Public Device Record Key
bb379bec-34dd-4155-b775-c5b2937e76e4
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
February 12, 2021
Package DI Number
50888439997093
Quantity per Package
7
Contains DI Package
10888439997095
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |