Duns Number:169260325
Device Description: 6" Standardbore Pressure-Rated (max 325 psi) Extension Set with Nexus NIS®-6P, Rotating Lu 6" Standardbore Pressure-Rated (max 325 psi) Extension Set with Nexus NIS®-6P, Rotating Luer & Pinch Clamp
Catalog Number
-
Brand Name
Nexus NIS®
Version/Model Number
N6960P-B
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
K130416,K130416
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
4a19bff5-cb7d-452c-971e-caf094f2fd65
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 12, 2016
Package DI Number
30892855000769
Quantity per Package
100
Contains DI Package
10892855000765
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 |