Duns Number:169260325
Device Description: 6" Bifurcated Microbore Pressure-Rated (max 325 psi) Extension Set with (2) Nexus TKO®-6P, 6" Bifurcated Microbore Pressure-Rated (max 325 psi) Extension Set with (2) Nexus TKO®-6P, Rotating Luer & Slide Clamps
Catalog Number
-
Brand Name
Nexus TKO®
Version/Model Number
N4691MN-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
-
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
c4a139f5-d662-4687-9aeb-f7640e49bae2
Public Version Date
February 24, 2021
Public Version Number
1
DI Record Publish Date
February 16, 2021
Package DI Number
30815879021343
Quantity per Package
100
Contains DI Package
10815879021349
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 |