Duns Number:080935429
Device Description: Gravity Extension Set. For use with ENFit Connection System.
Catalog Number
4VENS
Brand Name
Kangaroo
Version/Model Number
4VENS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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"
-
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
PNR
Product Code Name
Enteral Syringes with enteral specific connectors
Public Device Record Key
bb4c9758-996e-4033-a2a6-cabece25e715
Public Version Date
November 16, 2020
Public Version Number
3
DI Record Publish Date
June 07, 2018
Package DI Number
20884521703428
Quantity per Package
50
Contains DI Package
10884521703421
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |