Duns Number:618825723
Device Description: IV ADMINISTRATION SET, 100", 20 DROPS/ML, VENTED SPIKE, DRIP CHAMBER, IN LINE SOLUTION FIL IV ADMINISTRATION SET, 100", 20 DROPS/ML, VENTED SPIKE, DRIP CHAMBER, IN LINE SOLUTION FILTER, ONE KEN_SEF SPLIT SEPTUM Y SITE, KEN_ROL MALE ROTATING LUER LOCK CONNECTOR, FLOW REGULATOR.
Catalog Number
937020
Brand Name
KENAFLEXX
Version/Model Number
937020
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
d1e49e65-6e6e-4b3c-b5a2-9b27ca83dd48
Public Version Date
December 19, 2018
Public Version Number
1
DI Record Publish Date
November 18, 2018
Package DI Number
10810003750010
Quantity per Package
50
Contains DI Package
00810003750013
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 |