Duns Number:169260325
Device Description: Blood Collection Assembly with Male Luer Lock
Catalog Number
-
Brand Name
IV Plus®
Version/Model Number
BD6010
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
KST
Product Code Name
System, Blood Collection, Vacuum-Assisted, Manual
Public Device Record Key
ffae070e-5fb2-477a-8408-774e2976cfdf
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
June 09, 2017
Package DI Number
30815879021015
Quantity per Package
200
Contains DI Package
10815879021011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 180 |