Duns Number:618825723
Device Description: 20" IV EXTENSION SET WITH FEMALE LUER AND ROTATING MALE LUER LOCK, FLOW BCONTROLLER AND TH 20" IV EXTENSION SET WITH FEMALE LUER AND ROTATING MALE LUER LOCK, FLOW BCONTROLLER AND THREE WAY STOP COCK.
Catalog Number
950020
Brand Name
KENAFLEXX
Version/Model Number
950020
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
44d59b34-6d29-48ff-8f8c-d87fb27f32f5
Public Version Date
December 19, 2018
Public Version Number
1
DI Record Publish Date
November 18, 2018
Package DI Number
10852244007874
Quantity per Package
50
Contains DI Package
00852244007877
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 |