Duns Number:618825723
Device Description: IV ADMINISTRATION SET, 78", VENTED SPIKE, DRIP CHAMBER, FLOW REGULATOR, 2 KEN_SEF SPLIT SE IV ADMINISTRATION SET, 78", VENTED SPIKE, DRIP CHAMBER, FLOW REGULATOR, 2 KEN_SEF SPLIT SEPTUM Y SITES, KEN_ROL MALE ROTATING LUER LOCK CONNECTOR.
Catalog Number
937062
Brand Name
KENAFLEXX
Version/Model Number
937062
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
6c8db1c0-bdcf-49f4-9b50-e5b93b012a45
Public Version Date
December 19, 2018
Public Version Number
1
DI Record Publish Date
November 18, 2018
Package DI Number
10810003750058
Quantity per Package
50
Contains DI Package
00810003750051
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 |