Duns Number:961027315
Device Description: Connect ENPlus Spike ENtelliSetAnti-free flow
Catalog Number
1KCP
Brand Name
Kangaroo
Version/Model Number
1KCP
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"
Yes
For Single-Use
-
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
LZH
Product Code Name
Pump, infusion, enteral
Public Device Record Key
f3cbc68b-850c-4cbb-b97f-d44d43ac7b77
Public Version Date
October 17, 2022
Public Version Number
3
DI Record Publish Date
September 04, 2020
Package DI Number
50885380166004
Quantity per Package
30
Contains DI Package
10885380166006
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |