Duns Number:169260325
Device Description: 4” Quadfurcate Extension Set with (3X) TKO-6P One-Way, (1X) TKO-6P Two-Way, Rotating Luer 4” Quadfurcate Extension Set with (3X) TKO-6P One-Way, (1X) TKO-6P Two-Way, Rotating Luer and Pinch Clamps
Catalog Number
-
Brand Name
Nexus TKO®
Version/Model Number
PTB6842N-1W/2R
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
dfb88f70-14de-48c3-af0e-377e2c4a5b98
Public Version Date
October 04, 2021
Public Version Number
1
DI Record Publish Date
September 24, 2021
Package DI Number
30815879021510
Quantity per Package
100
Contains DI Package
10815879021516
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 |