Duns Number:043537671
Device Description: IV START KIT
Catalog Number
-
Brand Name
Stradis Medical, LLC.
Version/Model Number
IV-760
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
b9d64a55-e3f0-4625-8983-ffa05f57e6af
Public Version Date
May 07, 2021
Public Version Number
3
DI Record Publish Date
April 23, 2018
Package DI Number
M765IV7605
Quantity per Package
50
Contains DI Package
M752IV7600
Package Discontinue Date
May 05, 2021
Package Status
Not 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 |