Duns Number:043537671
Device Description: Catheter Securement Device
Catalog Number
-
Brand Name
Stradis Medical, LLC
Version/Model Number
CPD-2000
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
KMK
Product Code Name
Device, Intravascular Catheter Securement
Public Device Record Key
e28074eb-d2fe-4f29-8f64-ffc00516417e
Public Version Date
April 22, 2020
Public Version Number
1
DI Record Publish Date
April 14, 2020
Package DI Number
M752CPD20003
Quantity per Package
12
Contains DI Package
M752CPD20000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner 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 |