Duns Number:080935429
Device Description: Kangaroo Connect KCP Enteral Feeding Set, 500 mL Bag, Feed Only, Non-Sterile
Catalog Number
500KCP
Brand Name
Kangaroo
Version/Model Number
500KCP
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
LZH
Product Code Name
Pump, infusion, enteral
Public Device Record Key
3154cad8-26c5-492f-b8be-e5506029cda1
Public Version Date
December 31, 2019
Public Version Number
2
DI Record Publish Date
December 18, 2019
Package DI Number
10884521747791
Quantity per Package
30
Contains DI Package
20884521747798
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 |