Duns Number:618825723
Device Description: I.V. ADMINISTRATION SET 60 DROPS WITH 2 KEN_SEF CONNECTORS
Catalog Number
936424
Brand Name
KENAFLEXX
Version/Model Number
936424
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
LHI
Product Code Name
Set, I.V. Fluid Transfer
Public Device Record Key
cf42a083-a4c3-4661-b8b3-46c6f1736256
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 15, 2016
Package DI Number
10852244007188
Quantity per Package
50
Contains DI Package
00852244007181
Package Discontinue Date
-
Package Status
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 155 |