Duns Number:080935429
Device Description: Needleless Connector,Neutral Displacement Valve with 6 Inch (15.2 cm) Extension Set
Catalog Number
2000NP
Brand Name
Kendall
Version/Model Number
2000NP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2022
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"
-
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
3db70dec-412a-4bc4-832c-08201c0bb3d7
Public Version Date
June 30, 2022
Public Version Number
11
DI Record Publish Date
September 24, 2016
Package DI Number
10884521184367
Quantity per Package
100
Contains DI Package
20884521184364
Package Discontinue Date
June 30, 2022
Package Status
Not 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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |