Duns Number:174262477
Device Description: IV Start Kit
Catalog Number
-
Brand Name
Stradis Medical, LLC.
Version/Model Number
IV-17065
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
400bc29a-9e28-4014-b491-3745030d0565
Public Version Date
December 11, 2019
Public Version Number
2
DI Record Publish Date
May 30, 2018
Package DI Number
M752IV170655
Quantity per Package
50
Contains DI Package
M752IV170650
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 |