Duns Number:005146311
Device Description: Non-DEHP High Flow Rate Extension Set, Male Luer Lock Adapter
Catalog Number
2N3346
Brand Name
NA
Version/Model Number
2N3346
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
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
08b327db-56f2-4c34-afe1-c5bab85e3e4c
Public Version Date
August 13, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
50085412004803
Quantity per Package
50
Contains DI Package
00085412004808
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 358 |