Duns Number:042928915
Device Description: 6” (15.25cm Standard bore extension set with pinch clamp male luer lock with non-bonded ne 6” (15.25cm Standard bore extension set with pinch clamp male luer lock with non-bonded needle-free connector )
Catalog Number
-
Brand Name
FK20201E
Version/Model Number
FK20201E
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"
-
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
18667398-65b8-4196-a13f-8f9cf80643ce
Public Version Date
March 29, 2019
Public Version Number
1
DI Record Publish Date
March 21, 2019
Package DI Number
10850005864001
Quantity per Package
100
Contains DI Package
00850005864004
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |