Duns Number:042928915
Device Description: 5” (13cm) Bi-fuse Minibore extension set with 2 slide clamps male luer lock and 2 bonded n 5” (13cm) Bi-fuse Minibore extension set with 2 slide clamps male luer lock and 2 bonded needle-free connectors
Catalog Number
-
Brand Name
FK20211E
Version/Model Number
FK20211E
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
81489711-8e34-45b9-b5dc-c9fde6453b32
Public Version Date
April 05, 2019
Public Version Number
1
DI Record Publish Date
March 28, 2019
Package DI Number
10850005864155
Quantity per Package
100
Contains DI Package
00850005864158
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 |