Duns Number:174262477
Device Description: IV Start Kit With Securement
Catalog Number
-
Brand Name
Stradis Medical, LLC
Version/Model Number
IM1208
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"
-
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
394401d0-cd4b-4634-a396-17c82346f3d9
Public Version Date
December 11, 2019
Public Version Number
3
DI Record Publish Date
November 13, 2017
Package DI Number
M752IM12085
Quantity per Package
50
Contains DI Package
M752IM12080
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 | 1226 |
2 | A medical device with a moderate to high risk that requires special controls. | 1431 |
U | Unclassified | 10 |