Duns Number:618825723
Device Description: 12" IV EXTENSIO SET WITH FEMALE LUER CONNECTOR, KENTRON GRAVITO FLOW CONTROLLER, ONE KEN_F 12" IV EXTENSIO SET WITH FEMALE LUER CONNECTOR, KENTRON GRAVITO FLOW CONTROLLER, ONE KEN_FLO Y SITE, SLIDING CLAMP, KEN_ROL MALE ROTATING LUER LOCK CONNECTOR.
Catalog Number
940013
Brand Name
KENAFLEXX
Version/Model Number
940013
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
c6405147-562c-4e27-ae2e-335254cd10e7
Public Version Date
December 19, 2018
Public Version Number
1
DI Record Publish Date
November 18, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |