Duns Number:043537671
Device Description: Arterial line Dressing Change Kit - GUARDIVA 4MM
Catalog Number
-
Brand Name
Stradis Medical, LLC.
Version/Model Number
HCT900AGD-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
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
PEZ
Product Code Name
Central Venous Catheter Dressing Change Kit
Public Device Record Key
3f5e010e-71f8-40f4-a355-418c5f8e4691
Public Version Date
October 06, 2020
Public Version Number
2
DI Record Publish Date
July 23, 2020
Package DI Number
M752HCT900AGD15
Quantity per Package
30
Contains DI Package
M752HCT900AGD10
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
OUTER BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |